MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-340
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot specific voluntary recall ra 2016-028 was initiated for the lift 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 (b)(6) 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.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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Head disassociated from the stem.
Event or Problem Description
Head disassociated from the stem.
Additional Manufacturer Narrative
An event regarding disassociation and fretting involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: product evaluation and results: the device was returned for evaluation.Damage is visible on the head, damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of a capa.No further material analyses were performed.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: patient underwent primary left total hip arthroplasty.Eight years later the implant failed due to corrosion, metallosis and disassociation of the femoral head off the trunnion.I can confirm that the event occurred since i was able to review the operative reports and i reviewed the x-rays.Regarding the possible root cause of this event, i cannot determine this for sure.Causes could be multi factorial including in adequate cleansing and drying of the trunnion and possibly the combination of a high offset femoral head coupled with a 127 degree neck shaft angle.This cannot be determined with certainty.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 lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: patient underwent primary left total hip arthroplasty.Eight years later the implant failed due to corrosion, metallosis and disassociation of the femoral head off the trunnion.I can confirm that the event occurred since i was able to review the operative reports and i reviewed the x-rays.Regarding the possible root cause of this event, i cannot determine this for sure.Causes could be multi factorial including in adequate cleansing and drying of the trunnion and possibly the combination of a high offset femoral head coupled with a 127 degree neck shaft angle.This cannot be determined with certainty.Lot specific voluntary recall ra 2016-028 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.

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11645416
• Report Number: 0002249697-2021-00659
• Device Sequence Number: 11553540
• Product Code: JDI
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 09/30/2015
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: MJMAA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR