MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-226
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
After inserting the stem into the femur and firmly driving the inner head reported this time, surgeon inserted a bipolar cup and tried to reduce it.Then, the inner head was disengaged from the stem rolled down to the outside.So the head became dirty.The bipolar cup and inner head were raised one size.
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the returned device noted the following: visual inspection of the returned device identified nothing remarkable to report.Dimensional inspection: the device is dimensionally within specification as per inspection completed by manufacturing cell representative.Inspection report attached.Functional inspection: functional inspection of the returned device noted the following: material analysis: not performed as this event does not relate to material integrity.-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 exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
After inserting the stem into the femur and firmly driving the inner head reported this time, surgeon inserted a bipolar cup and tried to reduce it.Then, the inner head was disengaged from the stem rolled down to the outside.So the head became dirty.The bipolar cup and inner head were raised one size.

• Brand Name: 26MM +4 V40 TAPER VIT HEAD
• 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: 11832625
• Report Number: 0002249697-2021-00864
• Device Sequence Number: 17074883
• Product Code: JDI
• UDI-Device Identifier: 07613327012880
• UDI-Public: 07613327012880
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 6260-5-226
• Device Catalogue Number: 6260-5-226
• Device Lot Number: 77226603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR