MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-440
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Right hip revision for instability.Stem, insert, and head were revised.Per response: removal of stem was not planned during revision it was removed however as a result of intra-op event, "when the constrained inserts failed, stem removal was necessary".
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.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
Right hip revision for instability.Stem, insert, and head were revised.Per response: removal of stem was not planned during revision it was removed however as a result of intra-op event, "when the constrained inserts failed, stem removal was necessary.".
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a metal head that was mated with an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the device was not returned but photographs were provided for review.A review of the provided photographs indicated the device is covered in blood.The device has slight damage consistent with explantation.Material analysis, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "revision of a tha can be confirmed by the intra-operative photographs.There is no documentation regarding the cause for revision being instability.Nor was any documentation provided indicating evidence of intra-operative failure as noted in the pi.The root cause for the revision surgery cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment." device 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 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.

• Brand Name: V40 COCR LFIT HEAD 40MM/+12
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15316977
• Report Number: 0002249697-2022-01262
• Device Sequence Number: 20134527
• Product Code: JDI
• UDI-Device Identifier: 07613327032772
• UDI-Public: 07613327032772
• Combination Product (Y/N): N
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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: 6260-9-440
• Device Catalogue Number: 6260-9-440
• Device Lot Number: MJMJRM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2010
• 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: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female