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

Model Number	6260-5-126
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that, during a bha, a head did not slide smoothly on the sliding surface of the reported centrax.Spare head and centrax were used instead.
Event or Problem Description
It was reported that, during a bha, a head did not slide smoothly on the sliding surface of the reported centrax.Spare head and centrax were used instead.
Additional Manufacturer Narrative
Reported event: an event regarding size / fit issue involving a v40 taper vit head was reported.The event was not confirmed.Method & results: -device evaluation and results: the returned device has been assembled with centraxe.The metal head was disassemble for dimensional inspection.The inspection concluded that the metal head was dimensionally within specification.-clinician review: no medical records were received for review with a clinical consultant.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the returned device has been assembled with centraxhe.The metal head was disassemble for dimensional inspection.The inspection concluded that the metal head was dimensionally within specification.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be re-opened.

• Brand Name: 26MM STD 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: 8775520
• Report Number: 0002249697-2019-02544
• Device Sequence Number: 2374561
• Product Code: JDI
• UDI-Device Identifier: 07613327012859
• UDI-Public: 07613327012859
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 01/31/2024
• Device Model Number: 6260-5-126
• Device Catalogue Number: 6260-5-126
• Device Lot Number: 69896102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/20/2020
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/13/2020
• 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