MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-232
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding an abnormal ion level and corrosion involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted metal head with black matter present in the taper.It cannot be determined if the black matter is metal debris or biological matter, therefore, abnormal ion level and corrosion cannot be confirmed.Medical records received and evaluation: no medical records were received for review with a clinical consultant product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: 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
It was reported that the patient's left hip was revised due to elevated chromium levels, and suspected corrosion of the head/ trunnion interface.Intra-operatively, corrosion was confirmed.A stem, head and liner were revised to a restoration modular stem construct, ceramic head, and mdm/adm liner construct.Rep provided explant pictures and reported that x-rays, medical records, and additional information are not available.

• Brand Name: 32MM +4 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: 8367293
• Report Number: 0002249697-2019-01174
• Device Sequence Number: 1332255
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

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: 01/31/2010
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 11886301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/25/2019
• 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: 82 YR