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

Model Number	6260-9-340
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding disassociation involving a lfit v40 cocr head was reported.The event was confirmed.Method & results: device evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted stem, damage consistent with loss of taper lock was observed on the stem trunnion.Clinician review: no medical records were received for review with a clinical consultant.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 subject device has been identified to be within scope of a nc and a capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of said 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
It was reported that following a hip implant on the left hip the patient was not able to bear weight.It was discovered upon x ray that the head of the stem was bent and the trunion displayed wear patterns.Based on this information the left hip was revised.

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• 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: 10048093
• Report Number: 0002249697-2020-00897
• Device Sequence Number: 14292361
• Product Code: LPH
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 12/31/2011
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: 8JEMRAX1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 05/12/2020
• 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