MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0335
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The customer reported that a patient who had been implanted with an accolade tmzf stem in 2009 was revised as the trunion has worn.The patient¿s hip ¿gave way¿ in the shower and they¿ve had pain for 6 months.
Additional Manufacturer Narrative
Reported event: an event regarding fretting (trunnion wear) involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was confirmed via provided photo.Method & results: product evaluation and results: the reported device was not returned however a photograph was provided for review.The stem trunnion was severely worn and penciled to a pointed tip.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 19-nov-2008 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient¿s hip ¿gave way¿ in the shower and they¿ve had pain for 6 months.The patient's hip was revised due to worn trunnion.The provided photo indicated that the stem trunnion was severely worn and penciled to a pointed tip.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of a capa.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.
Event or Problem Description
The customer reported that a patient who had been implanted with an accolade tmzf stem in 2009 was revised as the trunion has worn.The patient¿s hip ¿gave way¿ in the shower and they¿ve had pain for 6 months.

• Brand Name: ACCOLADE TMZF HIP STEM #3
• 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: 11237272
• Report Number: 0002249697-2021-00175
• Device Sequence Number: 16977889
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: 6020-0335
• Device Catalogue Number: 6020-0335
• Device Lot Number: 28109802
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: 70 YR