MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM G POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

It was reported that patient's right hip was revised due to pain and dislocation.

Event Description

It was reported that patient's right hip was revised due to pain and dislocation.

Manufacturer Narrative

An event regarding pain and dislocation involving an unknown liner was reported.The event was not confirmed.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, additional x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

• Brand Name: 32MM G POLY LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7251417
• MDR Text Key: 99348739
• Report Number: 0002249697-2018-00364
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 114