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

Catalog Number 6260-9-232

Device Problems Corroded (1131); Material Integrity Problem (2978)

Patient Problems Inflammation (1932); Injury (2348)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.

Event Description

Surgeon revised patients left hip due to suspected trunnionosis.

Event Description

Surgeon revised patients left hip due to suspected trunnionosis.Update 11-march-2019: its alleged by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total hip arthroplasty on (b)(6) 2013 that failed and required revision on (b)(6) 2015 due to elevated levels of cobalt and chromium revealed in blood work.

Manufacturer Narrative

Corrected data: patient identifier, manufacturing site for devices.An event regarding abnormal ion level involving an metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records or x-rays were made available for evaluation.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.  conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including return of device, x-rays, pathology report, operative reports and progress notes are needed to complete the investigation for determining the root cause.If further information and / or device become available, this investigation will be re-opened.

• Brand Name: 32MM +4 LFIT V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5226181
• MDR Text Key: 31331318
• Report Number: 0002249697-2015-03734
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K010757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 40999401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR