MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 22/140; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Event description: it was reported that the patient was implanted with a revitan stem on an unknown date in 2011 and underwent a revision of the stem in 2020 due to implant fracture in the area of the connection.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Revision report: the clinical summary section of the report states that a 65 year-old patient underwent a revision of a right total hip prosthesis in 2011 which involved removal of a spacer and implantation of a revision hip prosthesis.Recently there was a sudden loss of function of the right hip in relation with a fracture of the revitan stem.The fracture is located at the level of taper connection.The hip joint is stiffened due to peri-prosthetic ossifications, but the bone is well reconstructed.The distal part of the stem is perfectly osseointegrated.The procedure section of the report states that since the prosthesis is perfectly integrated distally, a femoral flap approach is performed 17 cm below the tip of the greater trochanter.The flap is lifted at the price of additional fractures.The diaphysis is perfectly osseointegrated, particularly distally, which means that an additional distal flap has to be made.The prosthesis is finally released gradually and then removed at the price of multiple internal cortical fractures.After calculating the height, the entire prosthesis is removed, including the metaphyseal part.Further the report describes the steps to prepare the acetabulum and the femur to implant a sagitta stem, a head and a novae insert.Femoral reconstruction around the stem is made using 5 cerclages and by filling all the cortical bone defects with all the bone recovered during the various fracture events.Product evaluation: visual examination: in the as-received condition the head, the dual mobility insert and the proximal part of the revitan stem were still assembled.For further investigation the head was disassembled from the stem.Before the disassembly the stem to head position was marked.The dual mobility insert was left connected to the head.The connection pin of the revitan stem is fractured in the non-blasted area.The fracture is located approximately 3 to 6 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 fracture surface exhibits a fatigue fracture with a main large fracture level and two smaller fracture levels in the lateral one third.For the two smaller fracture levels, several adjacent fracture planes are recognizable and each seems to have its own fracture origin along the anterolateral side.These fracture planes then combine to form a single level.The distal fracture surface exhibits only one fracture level, with the origin on the lateral side.Therefore it is assumed that several smaller fragments from the proximal fracture surface are missing.Polishing and scratches can be seen on both proximal and distal fracture surfaces.Macroscopically, as far as visible, no defects that could have triggered or favored the fracture were found on the fracture surfaces.On the face surface of the proximal stem part slightly polished areas can be seen on the posterior side and on the medial half of the medial shoulder.The lateral edge of the lateral shoulder is slightly worn.The lateral face surface of the distal stem part and the lateral inside of the stem body are worn.The medial edge of the medial face surface of the distal stem part is slightly worn.On the proximal part of the revitan stem, revision damage in the form of scratches and instrument marks can be seen on the neck and anchoring surface.On the anchoring surface, among the revision damage, slightly polished horizontal lines can be observed on the medial side and on the posterior side.Some polished areas can be recognized on the distal end of the lateral side.There are no signs of bone ongrowth on the anchoring surface of the proximal stem part.The taper surface is dark discolored.On the proximal fracture part of the connection pin there is a circumferential stripe revealing surface changes adjacent to the fracture surface.Closer inspection of the stripe with a low power microscope revealed polishing, smeared material, fretting and corrosion.Adjacent to the stripe joins the original surface followed by the blasted area.Revision damage in the form of coarse scratches, instrument marks and a lateral bore hole can be observed on the distal part of the revitan stem.Bone attachments are visible on the entire anchoring surface.On the taper surface of the tete chrome-cobalt cone signs of fretting and corrosion can be observed.The novae dual mobility insert was inspected, however nothing was observed that could have had an influence on the fracture of the connection pin and the part is therefore not further described.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was not approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: according to the revision report the patient underwent a sixth revision of the right hip in 2011 where a spacer was removed and a revitan stem was implanted.The revitan stem was revised on (b)(6) 2020 due to a fracture of the connection pin.Apart from the revision report, there is no further clinical information at hand (e.G.Implantation report, complete x-ray follow-up, etc.) and therefore the further background of the situation stays unknown.Investigation of the retrievals at hand showed that the fracture of the revitan stem 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 proximal fracture surface exhibits a main fracture level and two smaller fracture levels whereas the distal fracture surface exhibits only one fracture level.Therefore it can be assumed that several smaller fragments from the proximal fracture surface are missing.For the two smaller fracture levels on the proximal fracture surface, several adjacent fracture planes were recognized and each seems to have its own fracture origin along the anterolateral side.The distal fracture surface shows an origin on the lateral side.Macroscopically, as far as visible, no defects that could have triggered or favored the fracture could be found on the fracture surfaces.On the proximal fracture part of the pin there is a circumferential stripe revealing a mixture of surface changes.It is unknown if the stripe existed already before the start of the fracture or developed exclusively as a concomitant phenomenon.Bone attachments could be observed on the distal part of the revitan stem, in agreement with the revision report that states that the diaphysis is perfectly osseointegrated.On the proximal part there are no bone attachments visible.Further, some polished areas and slightly polished horizontal lines can be seen on the anchoring surface of the proximal part which indicates movement between the part and the surroundings.It is unknown if these 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.According to the product compatibility table available to the operating surgeon on www.Productcompatibility.Zimmer.Com the tete chrome-cobalt cone was not released by zimmer biomet to be used in combination with the revitan stem.Therefore this head/stem combination has to be considered off-label use.In addition, the metallic head was used in combination with a dual mobility insert from another manufacturer (serf).This is also an unauthorized combination and is considered off-label use.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).Based on the retrieval investigation and the received information the reason for the fracture stays unknown.The need for corrective measures is not indicated and zimmer (b)(4) manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted in 2011 and underwent hip revision surgery due to fracture.

• Brand Name: REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 22/140
• Type of Device: PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MAUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12216256
• MDR Text Key: 263095988
• Report Number: 0009613350-2021-00346
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2021

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: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.122
• Device Lot Number: 2453013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention