MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM -3 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-026
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
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.Device evaluated by mfr: device not returned.
Event or Problem Description
After the head is attached, the head come off from the stem during bipolar mounting.Bipolar locking is also half locking, and there is a doubt that the head is not fitted properly, another head used and continuing the operation.
Additional Manufacturer Narrative
An event regarding an assembly issue involving a metal head was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection of the returned device noted nothing remarkable to report.Dimensional inspection on the femoral head id (taper) was performed on the returned device and confirmed that the returned device is within specifications for assembly.Functional inspection could not be performed as the returned head is currently assembled into a bipolar component, which could be damaged when the assembly is taken apart for functional inspection.Material analysis is not performed as this is not related to material integrity.-medical records received and evaluation: 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: dimensional inspection on the femoral head id (taper) was performed on the returned device and confirmed that the returned device is within dimensional specifications for assembly.The exact cause of the event could not be determined.No further investigation is applicable at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
After the head is attached, the head come off from the stem during bipolar mounting.Bipolar locking is also half locking, and there is a doubt that the head is not fitted properly, another head used and continuing the operation.

• Brand Name: 26MM -3 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: 8518010
• Report Number: 0002249697-2019-01615
• Device Sequence Number: 11242931
• Product Code: JDI
• UDI-Device Identifier: 07613327012828
• UDI-Public: 07613327012828
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 12/31/2023
• Device Catalogue Number: 6260-5-026
• Device Lot Number: 69323102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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