MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +12 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6260-9-432
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
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
Primary revision of a right hip.Head dissociated from the stem and excessive wear of the trunnion.The patient was revised to a restoration modular system and a biolox head.There are no allegations against the liner.Images are provided.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was confirmed via photographs.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head with nothing remarkable to report.However, the photographs also show the stem trunnion is severely damaged.From the photographs provided there is evidence of disassociation for the device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: 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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Primary revision of a right hip.Head dissociated from the stem and excessive wear of the trunnion.The patient was revised to a restoration modular system and a biolox head.There are no allegations against the liner.Images are provided.

• Brand Name: 32MM +12 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9437540
• Report Number: 0002249697-2019-03979
• Device Sequence Number: 14078425
• Product Code: LPH
• UDI-Device Identifier: 07613327013153
• UDI-Public: 07613327013153
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: 10/31/2007
• Device Catalogue Number: 6260-9-432
• Device Lot Number: 8586512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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: Hospitalization; Required Intervention