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

Model Number 6020-0435

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 12/28/2008

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.

Event Description

Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.

Manufacturer Narrative

An event regarding loosening & pain involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product remains implanted.- clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: x-ray printouts include a series dated november 1, 2019, which is an ap of the pelvis and lateral of the right hip demonstrating bilateral uncemented total hip arthroplasties with no screws in the acetabular component.The right hip demonstrates brooker iii heterotopic ossification.X-rays dated (b)(6) 2019 are an ap of the pelvis and lateral of the right hip, which is unchanged.Based upon the information available for review, there is no indication that any symptoms described as related to the right total hip arthroplasty are due to the prosthetic components and the recall of the implanted prosthetic femoral head.Persistent lumbar pathology and radicular pain, as well as heterotopic ossification are more likely the cause of the symptoms described.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the patient would like to know if his implants were part of a recall.The accolade stem was determined not to be involved in recall.The exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9693266
• MDR Text Key: 188708297
• Report Number: 0002249697-2020-00259
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: 6020-0435
• Device Catalogue Number: 6020-0435
• Device Lot Number: 26167401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR