MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Degraded (1153)

Patient Problems Injury (2348); Reaction (2414)

Event Date 06/05/2019

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.

Event Description

It was reported that the patient's left hip was revised due to disassociation of the head from the stem.Intra-operatively, excessive black tissue was noted and the trunnion was observed to be worn (reported as "pencilled").Patient was revised to a restoration modular stem construct with a ceramic head and a liner (there are no allegations against the original liner).

Manufacturer Narrative

An event regarding disassociation and wear at taper resulting in blackened tissue involving an unknown accolade tmzf stem was reported.The disassociation event was confirmed based on medical review.Method & results -product evaluation and results: not performed as product was not returned.¿ -clinician review:¿a review of the provided medical records by a clinical consultant stated the following comment: "provided x-ray confirms disassociation.Need operative reports, office/clinical reports, examination of the explanted components, etc." -device history review: could not be performed as lot code information was not provided.¿ -complaint history review: could not be performed as lot code information was not provided.¿ conclusion:¿ while the disassociation event was confirmed based on the x-ray provided, the exact cause of the event could not be determined because insufficient information was provided.¿the reported wear and blackened tissue were not confirmed, and hence root cause could not be determined based on the provided information.Additional information including device details, operative reports, office/clinical reports, pathology reports and examination of the explanted components 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

It was reported that the patient's left hip was revised due to disassociation of the head from the stem.Intra-operatively, excessive black tissue was noted and the trunnion was observed to be worn (reported as "pencilled").Patient was revised to a restoration modular stem construct with a ceramic head and a liner (there are no allegations against the original liner).

• Brand Name: UNKNOWN ACCOLADE TMZF STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8750766
• MDR Text Key: 149754680
• Report Number: 0002249697-2019-02451
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR