MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140; N/A

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.An e-mail requesting the following additional information was sent to the appropriate representatives: please clarify the correct notification date: is it the 14.10.2019 or 15.10.2019.Ref: (b)(4) please provide us the lot number.Exact implant date.Implantation report.Revision report.All available x-rays during time in- vivo with printed date.All available intraoperative pictures.Patient dob, weight, height, bmi and all relevant history.Did a delay in the procedure occur that was related to the event? if yes, time surgery was extended? were there any contributing conditions related to the event? (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy) was the surgical technique for the product utilized? concomitant medical product: unknown revitan distal stem hip, item#: unknown, lot#: unknown.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

It was reported that product was implanted in 2006 and revised due to pain and implant fracture.

Event Description

Investigation has been completed.Note: product changed from proximal revitan to distal revitan component: distal revitan component added as main product with ref and lot number.Proximal revitan component and head added as associated products with ref and lot.Confirmed pin fracture.

Manufacturer Narrative

Investigation results were made available.Note: product changed from proximal revitan to distal revitan component: distal revitan component added as main product with ref and lot number.Proximal revitan component and head added as associated products with ref and lot.Confirmed pin fracture.D11: revitan, proximal part, cylindrical, uncemented, 55, taper 12/14; catalog#: 01.00402.055; lot#: 2337849, cocr head, m, 36/0, taper 12/14; catalog#: 01.01012.366; lot#: 2359496.Event description: it was reported that the product was implanted in 2006 and revised on (b)(6) 2019 due to pain and implant fracture.Review of received data: no medical data relevant to the case has been received.Product evaluation: visual examination: the connection pin of the revitan stem is fractured in the non-blasted area.The fracture is located approximately 1 to 5 mm below the proximal end of the distal part.The proximal part of the connection pin is still assembled to the proximal part of the revitan stem.The proximal and distal fracture surfaces show a fatigue fracture starting from the lateral side.Except for a small area in the middle, both the proximal and distal fracture surfaces are polished to a shine.In addition, some blackish discoloration can be seen on the fracture surfaces.On the proximal part of the revitan stem, revision damage in the form of scratches and nicks can be observed on the neck and on the anchoring surface.The proximal region of the taper is discolored.There are no signs of bone on growth on the anchoring surface of the proximal stem part.An area with horizontal polished lines can be observed on the posterior side of the anchoring surface extending to the medial side.On the lateral side slightly polished lines are recognizable amongst the revision damage.On the proximal fracture part of the connection pin there is an almost circumferential stripe revealing surface changes adjacent to the fracture surface.Closer inspection of the stripe with a low power microscope revealed polishing, smeared material, signs of fretting and corrosion as well as cracks.On the medial and lateral side of the stripe several break-outs can be noticed close to the fracture surface.One break-out on the lateral side is located within the fracture origin area.Adjacent to the stripe joins the blasted area.In the latter, a polished area can be seen on the posterior side of the pin, whereas on the anterior side a scratch and some deposits are visible.On the anchoring side of the distal part of the revitan stem bone attachments are visible.Removal damage in the form of scratches, nicks, drill marks and a bore hole can be recognized on the anchoring surface.The inside of the stem body is worn on the lateral and medial side as well as on the posterior nose.On the lateral side some material is deformed and bended over the lateral face surface of the stem.In the as-received condition the cocr head and the proximal part of the revitan stem were still assembled.For further investigation the parts were disassembled.Before the disassembly the stem to head position was marked.Several areas with dense scratches are visible on the articulation surface of the head.Around the equator and on the bottom bevel of the head, areas with coarse scratches and nicks can be observed, most probably deriving from revision surgery and/or shipping of the parts to zimmer biomet.The head taper is inconspicuous.Review of product documentation: device purpose: this device is 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.The manufacturing documents were inspected including the expiry date of the retrievals.Based on this and the reported year of implantation (2006) a time in vivo of approximately 13 years can be estimated.Conclusion: the revitan stem was revised after approximately 13 years in vivo because of its fracture.The latter occurred due to fatigue in the non-blasted area of the connection pin, few millimeters below the proximal end of the distal stem part.The fracture origin area is located on the lateral side of the stem.On the proximal fracture part of the pin there is an almost circumferential stripe revealing a mixture of surface changes.It is unknown if these changes existed already before the start of the fracture or developed exclusively as a concomitant phenomenon.The several polished areas and worn marks seen on the connection pin and the inside of the distal stem body point to movement between the parts, possibly for a longer time before the revision surgery.Bone attachments could be observed on the distal part of the revitan stem but not on the proximal part.Further, various polished areas can be seen on the anchoring surface of the proximal part.This indicates movement between the part and the surroundings.It is unknown if these areas existed already before the start of the fracture and are associated with it or developed exclusively as a concomitant.As there is no x-ray follow-up at hand, the bone support situation immediately after the implantation of the stem and how it developed over time in vivo is unknown.Further, with no patient information available (e.G.Bmi, type and level of physical activity, complete medical history, etc.) any influencing factors that may result from these aspects remain unknown.Based on the retrieval investigation and the received information the reason for the fracture stays unknown.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).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).

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140
• 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: 9250355
• MDR Text Key: 164263968
• Report Number: 0009613350-2019-00637
• Device Sequence Number: 1
• Product Code: MEH
• 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
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2008
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.120
• Device Lot Number: 2192419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR