MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 36MM +5 COBALT CHROMIUM LFIT V40 FEMORAL HEAD; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Metal Shedding Debris (1804); Delamination (2904); Device Dislodged or Dislocated (2923); Material Deformation (2976); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Erosion (1750); Inflammation (1932); Necrosis (1971); Pain (1994); Discomfort (2330); Injury (2348); Reaction (2414)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported patient's hip was revised.

Manufacturer Narrative

An event regarding disassociation involving an unknown head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: no information was received for review with a clinical consultant.Device history review: not performed as the device lot number is unknown.Complaint history review: not performed as the device lot number is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.

Event Description

On (b)(6) 2007 the patient was implanted with an accolade tmzf stem with a 36 mm +5 cobalt chromium lfit v40 femoral head on her left hip.Allegedly after the implantation of the stryker accolade system, in 2017, the patient began experiencing significant pain and discomfort in the area of the device and on (b)(6) 2017, further diagnostic workup and imaging studies confirmed that patient had suffered a disassociation of the left femoral component from the femoral head.It is further alleged that based upon these findings, revision surgery of the left hip was completed on (b)(6) 2017 and during that surgery the surgeon observed, among other things, evidence of significant metallosis including one or more of the following findings: the presence of copious black fluid in the hip joint, turbid fluid, erosion around the head-neck taper, and significant soft tissue necrosis requiring debridement.The surgeon also noted the presence of a massive amount of wear debris, deformity and delamination of metal at the trunnion between the accolade stem and the lfit v40 cobalt chromium femoral head.

• Brand Name: UNKNOWN 36MM +5 COBALT CHROMIUM LFIT V40 FEMORAL HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6490661
• MDR Text Key: 72736540
• Report Number: 0002249697-2017-01259
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85