MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-332
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348)
Date of Event	06/27/2018
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 reported discrepancies.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 had a left total hip replacement (b)(6) 2005.Patient has done well until recently.She showed up for follow up with pain.She was worked up and had elevated cocr levels and evidence of a soft tissue mass in her hip.She was scheduled for a revision.At the time of revision some soft tissue reaction was noted.The head was removed with several blows with a mallet and tamp.There was some burnishing of the head and neck but it appeared to be in good condition.It was cleaned and a new sleeve was impacted and tested.It was securely attached to the neck.The surgeon subsequently assembled a ceramic head and mdm head together placed the mdm liner in the shell.He then impacted the head.It was secure on the stem.The patient was stable through a full range of motion.The operation was completed successfully and the patient will continue to be monitored.Due to hospital policy no further information will be made available.

• Brand Name: 32MM +8 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: 7718318
• Report Number: 0002249697-2018-02293
• Device Sequence Number: 996365
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 01/30/2010
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 11511501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/25/2018
• 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
• Patient Weight: 67