MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0637
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's hip was revised due to trunnion damage.Update: "the head disassociated from the stem.Shell was not revised.Converted the liner to mdm.".
Event or Problem Description
It was reported that the patient's hip was revised due to trunnion damage.Update: "the head disassociated from the stem.Shell was not revised.Converted the liner to mdm.".
Additional Manufacturer Narrative
An event regarding fretting and disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event of fretting was confirmed by the provided photographs and the event of disassociation was not confirmed.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted stem with blood and tissue on it.Pencilling of the proximal tip of the trunnion is present on the stem which is consistent with fretting having occurred.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "date of implant (b)(6) 2010, date of explant 5/29/19.Primary tha and revision tha implant labels note revision to rest.Modular stem and mdm bearing.1 undated x-ray ap of right hip demonstrates an uncemented primary tha, reduced with suspicion of head/trunnion junction disruption.No operative reports or findings at revision surgery available.Insufficient data to create a report." -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 reported accolade stem was mated with a lfit v40 cocr head which has been identified to be within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a 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 march 4, 2011.The root cause analysis 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.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #6
• 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: 8728263
• Report Number: 0002249697-2019-02356
• Device Sequence Number: 13900130
• Product Code: LPH
• UDI-Device Identifier: 04546540510716
• UDI-Public: 04546540510716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 05/31/2015
• Device Catalogue Number: 6021-0637
• Device Lot Number: 33505901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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: 86 YR