MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-132
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/15/2019
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.
Event or Problem Description
Patient presented to the emergency department with a dislocated left hip.Xray indicated a dissociation of the stem and head as well as a damaged trunnion.A revision was performed and all implants were explanted.
Event or Problem Description
Patient presented to the emergency department with a dislocated left hip.Xray indicated a dissociation of the stem and head as well as a damaged trunnion.A revision was performed and all implants were explanted.
Additional Manufacturer Narrative
An event regarding disassociation (resulting in joint dislocation) involving an v40 femoral head mated with an accolade stem was reported.The disassociation event was confirmed through x-ray review.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: clinician review: the provided medical records were received by a clinician and subsequently rejected for completion of a medical review.The clinician indicated provided x-ray confirms disassociation.Need operative reports, office/clinical reports, examination of components, etc.-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: while the clinician could confirm the disassociation of the stem from the head (resulting in joint dislocation), the exact cause of the event could not be determined because insufficient information was provided.Trunnion damage was also reported to have occurred, however the reported damage could not be confirmed.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.

• Brand Name: 32MM STD LFIT 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: 8603752
• Report Number: 0002249697-2019-01920
• Device Sequence Number: 3020438
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 02/28/2014
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 29489704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR