MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0537
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to severe wear of the trunnion and notching on the medial side of the stem caused by the shell.Intra-operatively, metallosis was noted.The stem, head and liner were revised.Rep confirmed there are no allegations against the revised liner.
Event or Problem Description
It was reported that the patient's left hip was revised due to severe wear of the trunnion and notching on the medial side of the stem caused by the shell.Intra-operatively, metallosis was noted.The stem, head and liner were revised.Rep confirmed there are no allegations against the revised liner.
Additional Manufacturer Narrative
Reported event: an event regarding fretting involving an accolade stem which was mated with a lfit v40 cocr head was reported.The event was confirmed through clinician review.Method & results: product evaluation and results: no product was returned for evaluation, however photographs were provided for review.The photographs show a recently explanted stem.Blood is visible on the stem.Black tissue/ biological matter is visible on the body of the stem.The trunnion of the stem appears worn/damaged.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: event confirmation: the revision can be confirmed.The trunnion wear can be confirmed.The neck notching can be confirmed.The metallosis can be confirmed.Root cause: the root cause cannot be confirmed.The likely root cause would be related to the lfit recall.Examining the lot numbers of the implants in question may answer this question.The assertion that the event was caused by impingement of the neck/trunnion on the acetabular shell is unlikely.This may be confirmed by examining the liner/shell or perhaps from the intraoperative notes.More likely the head was tipping and wearing the neck infero-medially.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 reported lot.Conclusion: a review of the medical records provided by a clinical consultant confirms the event.The root cause cannot be confirmed.The likely root cause would be related to the lfit recall.Examining the lot numbers of the implants in question may answer this question.The assertion that the event was caused by impingement of the neck/trunnion on the acetabular shell is unlikely.This may be confirmed by examining the liner/shell or perhaps from the intraoperative notes.More likely the head was tipping and wearing the neck infero-medially.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc/capa.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: ACCOLADE TMZF HIP STEM #5
• 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: 10819615
• Report Number: 0002249697-2020-02400
• Device Sequence Number: 11204402
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 03/31/2016
• Device Model Number: 6020-0537
• Device Catalogue Number: 6020-0537
• Device Lot Number: 36247302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: 83 YR