MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM +10 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-336
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	05/25/2024
Type of Reportable Event	Serious Injury
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.
Event or Problem Description
Rep called to inform of a broken accolade trunnion in a case over the weekend.This was a revision surgery.Primary surgery was (b)(6) 2014.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation & wear involving a metal head was reported.The events were confirmed.Method & results: -product evaluation and results: the reported devices were not returned but photographs were provided for review.A review indicated recently explanted devices covered in blood.The head had what looked like black debris on the inner taper.Loss of taper lock between the head neck junction and the trunnion of the stem was fractured.The liner had damage consistent with explantation -medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "the ap and lateral x-rays show a press fit th with a head dissociated from a deformed trunnion.The photograph demonstrates significant metallosis within the hip.A head dissociation from a trunnion with significant material loss is confirmed.The root cause of this mechanical complication cannot be determined from the limited documentation provided.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: the reported devices were not returned but photographs were provided for review.A review indicated recently explanted devices covered in blood.The head had what looked like black debris on the inner taper.Loss of taper lock between the head neck junction and the trunnion of the stem was fractured.The liner had damage consistent with explantation.A review of the provided medical records by a clinical consultant indicated: "the ap and lateral x-rays show a press fit th with a head dissociated from a deformed trunnion.The photograph demonstrates significant metallosis within the hip.A head dissociation from a trunnion with significant material loss is confirmed.The root cause of this mechanical complication cannot be determined from the limited documentation provided.The subject device 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 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 march 4, 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.
Event or Problem Description
Rep called to inform of a broken accolade trunnion in a case over the weekend.This was a revision surgery.Primary surgery was (b)(6) 2014.

• Brand Name: V40 COCR LFIT HEAD 36MM +10 OFFSET
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19526548
• Report Number: 0002249697-2024-00878
• Device Sequence Number: 18017777
• Product Code: JDI
• UDI-Device Identifier: 07613327032321
• UDI-Public: 07613327032321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 6260-9-336
• Device Lot Number: MJNLYX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2024
• Supplement Date Received by Manufacturer: 08/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Unknown