MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-236

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported: symax stem with worn conus and loose head.

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.H3 other text : not returned.

Event Description

It was reported: sym ax stem with worn conus and loose head.

Manufacturer Narrative

An event regarding disassociation involving an metal head was reported.The event was confirmed through analysis of the device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head appears to have damage from the disassociation event and explantation.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.Clinician review: no medical records were received for review with a clinical consultant.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 subject device has been identified to be within scope of an nc and 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.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16865935
• MDR Text Key: 314525702
• Report Number: 0002249697-2023-00473
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: DH3MED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose