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	Difficult to Insert (1316); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
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
The taper lock did not work when the inner head is attached.Even though it was driven in, it can be easily detached be hand.So another product was used.
Additional Manufacturer Narrative
Reported event an event regarding seating/locking issue involving a metal head was reported.The event was not confirmed.Method & results -product evaluation and results: the device was returned for evaluation.There is no obvious damage noticed on the device.The device is dimensionally within specification as per inspection completed by manufacturing engineer.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the 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 during the surgery, the taper lock did not work when the inner head is attached.Even though it was driven in, it can be easily detached be hand.The device was returned for evaluation.There is no obvious damage noticed on the device.The device is dimensionally within specification as per inspection completed by manufacturing engineer.The exact cause of the event could not be determined.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
The taper lock did not work when the inner head is attached.Even though it was driven in, it can be easily detached be hand.So another product was used.

• 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: 11445095
• Report Number: 0002249697-2021-00399
• Device Sequence Number: 17025019
• Product Code: JDI
• UDI-Device Identifier: 07613327012859
• UDI-Public: 07613327012859
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 10/31/2025
• Device Model Number: 6260-5-126
• Device Catalogue Number: 6260-5-126
• Device Lot Number: 81022904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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