MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-5537
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/24/2019
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.Device not returned.
Event or Problem Description
Head disassociation and trunion disfiguration.
Additional Manufacturer Narrative
An event regarding disassociation and fretting of the trunion involving an accolade stem was reported.The event was confirmed through clinician review of the medical records provided and photographs of the explanted device.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 and head.The trunion of the stem is worn.Clinician review: a review of the provided medical records by a clinical consultant indicated: review of these records confirm a revision of a tha secondary to mechanical failure of the femoral component trunnion occurred.The root cause of this failure can not be established from the records provided.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event was confirmed through clinician review of the medical records provided and photographs of the explanted device.While clinician review indicated the root cause could not be confirmed, the subject device has been identified to be mated with an lfit v40 cocr head within scope of nc and capa.Lot specific voluntary recall pfa (b)(4) was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6) 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Head disassociation and trunion disfiguration.

• Brand Name: ACCOLADE 132 SIZE 5.5
• 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: 8804532
• Report Number: 0002249697-2019-02604
• Device Sequence Number: 342709
• Product Code: LPH
• UDI-Device Identifier: 04546540510648
• UDI-Public: 04546540510648
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 10/31/2014
• Device Catalogue Number: 6020-5537
• Device Lot Number: 31243701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: 75 YR
• Patient Weight: 89