MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIZE-36+5 HEAD; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Corroded (1131); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and should additional information become available, it will be reported in a supplemental report upon completion of the investigation.

Event Description

A (b)(6) man with (b)(6) presented with severe hip pain and difficulty walking 7.5 years after a total hip arthroplasty.The femoral head fixation had been manually checked after firm impaction with a head impactor.Radiographs made at 7.5 years confirmed dissociation of the femoral head.During revision total hip arthroplasty, black corrosion material, consistent with metal wear debris, extruded after the capsule was opened.The head was separated from the trunnion, with severe trunnion damage.The acetabular component was exposed first, and the polyethylene was removed.The cup was deemed to be in an appropriate position, and thus a new liner was impacted into place.Because of the trunnion damage, it was necessary to remove the femoral component, which required an extended femoral trochanteric osteotomy.A modular revision stem and a size-3612.5 ceramic head were used to reconstruct the femur.Case 3.

• Brand Name: UNKNOWN SIZE-36+5 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5966903
• MDR Text Key: 55262676
• Report Number: 0002249697-2016-02997
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2016

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/21/2016
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 217