MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 42MM OSTEONICS SHELL; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)

Patient Problem Injury (2348)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

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 Description

This report is for revision of primary left hip.In reporting a revision of patient's left hip on (b)(6) 2018, rep reported that the patient had been previously revised on (b)(6) 2016 at an out-of-state facility for reasons unknown.A competitor shell and stryker femoral head (liner manufacturer unknown) were revised to a competitor shell with a stryker mdm/adm liner construct, ceramic head, and adapter sleeve.Rep will be providing a 'patient packet' for the 2018 revision, and has no access to the out-of-state facility's records.As per information received via an operative report, revision was due to failed acetabular component - originally noted to be a competitor device, the hip construct was comprised of all stryker devices.As reported: ".We noted the acetabular component had a complete poly wear through in the posterior superior quadrant.There was also a slightly retroverted orientation of the acetabular component.There was noted to be several areas of osteolysis.".

Manufacturer Narrative

An event regarding loosening and osteolysis involving an unknown shell was reported.The event was confirmed through review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: review of these records confirm that multiple revision tha surgeries for loss of acetabular fixation occurred following the index implantation of an osteonics/stryker tha in 2003.At the first revision in 2016 the acetabular component was revised to a depuy cup.This went on to early failure and the development of peri-acetabular bone loss necessitating further surgery.The root cause of these failures cannot be determined.As insufficient information was available.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the root cause of these failures cannot be determined as insufficient information was available.Additional information progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This report is for revision of primary left hip.In reporting a revision of patient's left hip on (b)(6) 2018, rep reported that the patient had been previously revised on (b)(6) 2016 at an out-of-state facility for reasons unknown.A competitor shell and stryker femoral head (liner manufacturer unknown) were revised to a competitor shell with a stryker mdm/adm liner construct, ceramic head, and adapter sleeve.Rep will be providing a 'patient packet' for the 2018 revision, and has no access to the out-of-state facility's records.As per information received via an operative report, revision was due to failed acetabular component - originally noted to be a competitor device, the hip construct was comprised of all stryker devices.As reported: "we noted the acetabular component had a complete poly wear through in the posterior superior quadrant.There was also a slightly retroverted orientation of the acetabular component.There was noted to be several areas of osteolysis.".

• Brand Name: 42MM OSTEONICS SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7588004
• MDR Text Key: 110646928
• Report Number: 0002249697-2018-01762
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 68