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	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.This event was reported to stryker canada by health canada via mandatory hospital reporting: health canada reference #: (b)(4).
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: confirmation of event: based on the information provided in this product inquiry summary, i can confirm that the patient had a right total hip arthroplasty since i was able to see an operation report albeit with the date and other information redacted.I have no corroborating evidence regarding the clinical condition or planned revision since i have no office notes or xrays.Root cause analysis: assuming the events are the development of trunnionosis and the fracture of femoral stem, the root causes cannot be determined with certainty.The causes of trunnionosis are multifactorial including surgical technique, especially in the way that the trunnion and femoral head is prepared, patient factors including lifestyle, activity level and bmi.It is notable that this patient had an extremely high bmi 63.The root causes of a fractured femoral stem are multifactorial including surgical technique in the way the implant is secured and positioned as well as the ability to prevent the implant from being "potted" distally.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: it was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.A review of the provided medical records by a clinical consultant indicated: "based on the information provided in this product inquiry summary, i can confirm that the patient had a right total hip arthroplasty since i was able to see an operation report albeit with the date and other information redacted.I have no corroborating evidence regarding the clinical condition or planned revision since i have no office notes or xrays.' 'assuming the events are the development of trunnionosis and the fracture of femoral stem, the root causes cannot be determined with certainty.The causes of trunnionosis are multifactorial including surgical technique, especially in the way that the trunnion and femoral head is prepared, patient factors including lifestyle, activity level and bmi.It is notable that this patient had an extremely high bmi 63.The root causes of a fractured femoral stem are multifactorial including surgical technique in the way the implant is secured and positioned as well as the ability to prevent the implant from being "potted" distally.' the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 1757583 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
It was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.This event was reported to stryker canada by (b)(6) via mandatory hospital reporting: health canada reference #: (b)(4).

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21147961
• Report Number: 0002249697-2025-00084
• Device Sequence Number: 9097507
• Product Code: JDI
• UDI-Device Identifier: 07613327032321
• UDI-Public: 07613327032321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 01/31/2015
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MHT89A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2010
• 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: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown