MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0435
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The patient had a total hip replacement in 2008, recently fell and saw the doctor.The x-rays revealed an apparent failure of the neck of the femoral stem.The doctor elected to revise the prosthesis.Surgery revealed that the neck of the femoral stem was broken.The acetabular component was retained, the acetabular liner was revised, the femoral stem was removed and revised using the restoration modular system.
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving an accolade stem was reported.The event is confirmed based on medical review method & results -product evaluation and results: visual inspection: the device was not returned however photographs were provided for review and it can be observed that neck of the femoral stem is broken.Refer attached pics material analysis, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: event confirmed: dissociation of the v40 lfit femoral head from the accolade tmzf stem.Assessment of root cause:failure of trunnion-head construct has a possible relation to lfit head recall.Review of implant stickers could define if this was a recalled head lot.Obtaining the implant may provide additional insight into the mechanism of dissociation.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc pr 1096957 and capa pr 1319376.The event is confirmed based on medical review.Visual inspection:the device was not returned however photographs were provided for review and it can be observed that neck of the femoral stem is broken.Refer attached pics.A review of the provided medical records by a clinical consultant stated the following comment: event confirmed: dissociation of the v40 lfit femoral head from the accolade tmzf stem.Assessment of root cause:failure of trunnion-head construct has a possible relation to lfit head recall.Review of implant stickers could define if this was a recalled head lot.Obtaining the implant may provide additional insight into the mechanism of dissociation.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not available.
Event or Problem Description
The patient had a total hip replacement in 2008, recently fell and saw the doctor.The x-rays revealed an apparent failure of the neck of the femoral stem.The doctor elected to revise the prosthesis.Surgery revealed that the neck of the femoral stem was broken.The acetabular component was retained, the acetabular liner was revised, the femoral stem was removed and revised using the restoration modular system.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10390657
• Report Number: 0002249697-2020-01635
• Device Sequence Number: 3446507
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 6020-0435
• Device Catalogue Number: 6020-0435
• Device Lot Number: 25893303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR