MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 16/200; N/A

Model Number N/A

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: revitan proximal hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on an unknown side and experienced an implant fracture or a possible connecting bolt being knocked out.A revision surgery has been planned.

Event Description

Patient was implanted on the left side and underwent a revision surgery due to loosening of the connecting cone from the distal part.It shows a massive metallose.

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Additional information was received on dec 14, 2020.Medical products: revitan, proximal part, cylindrical, uncemented, 55, taper 12/14; catalog#: 01.00402.055; lot#: 2565238 durasul, alpha insert, oo/32; catalog#: 01.00013.415; lot#: 2435718 biolox head hip impl win gen; catalog#: unknown; lot#: unknown therapy date: nov 5, 2020 the manufacturer received x-rays and other source documents (surgical reports) for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the revitan was either broken or the connecting bolt knocked out.The revision surgery is expected to be on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: pelvis overview (b)(6) 2018: there are revitan total hip prostheses implanted in the left and right hip.Concerning the left hip, radiolucent gaps can be recognized between the cortical bone and the medial and lateral side of the proximal stem part which extend to the distal stem part until approximately the height of the first cerclage.The gaps are bordered on the bone side by a sclerotic line.Pelvis overview and second view x-rays, (b)(6) 2020: compared to the previous study date, the distance between the shoulders of the proximal part of the stem and the face surface of the distal part of the stem is not anymore visible medially and is slightly larger laterally.Medially the proximal part of the stem protrudes slightly the distal part of the stem.Thus, it seems that the proximal part of the revitan stem is slightly tipped medially.The medial and lateral radiolucent gaps are still visible.On the second view radiolucent gaps can be recognized between the cortical bone and the anterolateral and posteromedial side of the proximal stem part which extend to the distal stem part until approximately the height of the first cerclage.The gaps are bordered on the bone side by a sclerotic line.Pelvis overview, ap view and second view taken on (b)(6) 2020: compared to the previous study date, the proximal part of the revitan stem together with the distal portion of the connection pin are tipped medially.The radiolucent gap around the proximal part of the stem is wider laterally and narrower medially.The distal lateral end of the connection pin is resting against the lateral inside of the distal stem body.On the second view, the anterior and posterior radiolucent gaps are still visible.Pelvis overview, ap view and second view taken on (b)(6) 2020: the x-rays show the situation after the revision of the revitan stem and are not evaluated.Surgical report of revision: diagnosis: left hip: loosening of the connection pin from the distal part of the revitan stem: state after implantation of a total hip prosthesis in 1994.Revision of the acetabular cup in 2010 due to loosening.Subsequently in the post-operative course it came to a periprosthetic fracture of the femur and revision of the stem with a revitan as well as osteosynthesis by means of cerclages.Procedure: the hip joint is accessed through the old scar.The proximal two cerclages are removed as planned.Proximal to the middle cerclage, semi-circumferential drilling is performed to protect the osteotomy.This is now marked longitudinally over the entire length of approximately 18 cm and then performed step by step with the oscillating saw.The osteotomy is completed from distal medial to proximal with the appropriate chisel.The bone flap including the lateral vastus are held away medially.As expected, the proximal part of the stem is completely loose.The neocapsule is gradually exposed and resected.Massive metallosis is revealed.The prosthesis can now be dislocated without any problems and the proximal part including the head are removed.The capsule is resected and the cup is exposed.The inlay is removed.The shell itself is firmly integrated and can be left in place.Dorsally, there is a large cavity in the sense of a pseudotumor due to the extensive metallosis.This is partially debrided.A new durasul inlay is now inserted.The firmly integrated distal part of the stem is carefully and gradually chiseled.A hole is drilled in the stem.Using a reverse-blow hammer the distal part of the stem can be easily removed.Further, the report describes the steps to place a new revitan stem (distal part size 22/140 and proximal part size 105) and a biolox delta head (36l).Before the osteotomy is reduced allograft bone is inserted proximally medially and laterally.The osteotomy is then reduced almost anatomically and secured with 4 cerclages.Product evaluation: visual examination: the revitan stem was received disconnected at the connection between the connection pin and the distal stem body.The proximal part of the stem and the connection pin were still assembled.The proximal and distal part of the revitan stem exhibit some damage such as scratches, dents, a bore hole and instrument marks most likely deriving from revision surgery.On the proximal part of the revitan stem some polished spots/lines can be seen on the posterior side near the two bore holes.These polished spots/lines seem to extend slightly to the medial side of the part.There are no bone attachments noticeable on the proximal stem part.The posteromedial and anterolateral side of the distal face surface of the proximal stem part as well as the medial and lateral shoulders are worn.On the blasted surface of the connection pin there is a polished area medially.The press-fit region of the connection pin is not anymore in its original condition and shows a mixture of polishing, smearing and corrosion.The lateral side of the distal conical region of the pin exhibits polishing, smearing and an elliptical shaped groove.The anterolateral and posteromedial side of the proximal face surface of the distal stem and the anterior and posterior shoulders are worn.The inside of the stem body is worn posteromedially proximal so that the wall thickness is slightly diminished.On the lateral side a new ledge can be recognized further down.On the distal part of the revitan stem there are some bone attachments on the finned region of the anchoring surface.The other parts received, biolox delta head, the durasul alpha insert and 2 cerclage fragments, were inspected.However nothing was observed that could have had an influence on the loosening of the connection pin from the distal part of the stem and therefore they are not further described.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: according to the received information, in 2010, in the post-operative course of a revision of the acetabular cup it came to a subsequent periprosthetic femur fracture.Consequently, the stem was revised with a revitan stem and osteosynthesis was performed by means of cerclages.The revitan stem was revised approximately 10 years later due to a loosening of the connection pin from the distal stem part.Only x-rays taken in 2018, approximately 8 years after implantation of the revitan stem, and shortly before and after revision were received.Radiolucent gaps around the proximal stem part which extend slightly to the proximal region of the distal stem part can be observed from (b)(6) 2018 until shortly before revision in (b)(6) 2020.Starting in (b)(6)2020, the proximal stem part seems to be slightly tipped medially.In (b)(6) 2020 a further tipping of the proximal stem part together with the distal part of the connection pin is well recognizable.In agreement with the x-rays, the visual examination of the retrievals shows a disconnection of the pin from the distal stem body.Bone attachments could be observed on the distal part of the stem but not on the proximal part.The polished spots/lines seen on the posterior and medial side of the proximal part indicate movement between the part and the bone.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Today it is known that for patients with severe proximal deficiency, a surgeon should consider surgical options to ensure proximal bone support (such as medial and/or lateral strut grafts) or switching to a monobloc revision stem.At the time of implantation this was not known and respective guidance could not be provided to the surgeon.Based on the received information and today¿s knowledge which was unknown in 2010, it can be assumed that the proximal bone support of the revitan stem was suboptimal at least from (b)(6) 2018 until revision whereas the finned region of the distal stem part was well fixed.However, as the complete x-ray follow-up is not at hand, the bone support situation immediately after the implantation of the stem and how it developed until (b)(6) 2018 stays unknown.The suboptimal bone support could have led to an overload of the stem resulting in a loosening of the connection pin from the distal stem body.As there is no patient information at hand, further other possible contributing factors (e.G.Medical history, bmi, type and level of physical activity) remain unknown.After loosening, the connection pin could move inside the stem body and subside together with the proximal part.The subsidence led to contact between the face surfaces of the proximal and the distal part resulting in wear on both surfaces.Additionally, the load was not anymore completely borne by the connection pin.The loosening of the pin resulted in wear on the inside of the stem body.This allowed a little by little tipping of the pin to medial so that its distal end could rest on the inside of the stem body and form a new ledge distally lateral and a worn area posteromedially proximal.On the connection pin a mixture of polishing, smearing and corrosion was observed.The first two phenomena are most probably concomitants.However, it remains unclear whether the latter could have had an influence on the failure mode or is only a concomitant as well.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 16/200
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10780078
• MDR Text Key: 214410994
• Report Number: 0009613350-2020-00525
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.216
• Device Lot Number: 2546655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention