MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM STD V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-4-122
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.Device not returned.
Event or Problem Description
It has been reported by the customer that after procedure the metal head was dissociated from the stem neck.Update 05/february/2021: as also reported in the intake form: "returned to (revise) the patient to remove the implanted head and implanted bipolar cup and place a new one." update 08/february/2021, a hip implanted on 27/january/2021 failed and was revised on 29/january/2021.
Event or Problem Description
It has been reported by the customer that after procedure the metal head was dissociated from the stem neck.Update 05/february/2021: as also reported in the intake form: "returned to (revise) the patient to remove the implanted head and implanted bipolar cup and place a new one." update 08/february/2021, a hip implanted on (b)(6) 2021 failed and was revised on (b)(6) 2021.
Additional Manufacturer Narrative
Reported event an event regarding disassociation 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 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 the patient's hip was revised due to head disassociated from the stem neck.The head 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 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.

• Brand Name: 22.2MM STD V40 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: 11396701
• Report Number: 0002249697-2021-00355
• Device Sequence Number: 1165180
• Product Code: JDI
• UDI-Device Identifier: 07613327012798
• UDI-Public: 07613327012798
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 6260-4-122
• Device Catalogue Number: 6260-4-122
• Device Lot Number: 74946403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: Hospitalization; Required Intervention