MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC

Catalog Number	1236-2-852
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The surgeon revised a tha patient due to dislocation.With continued pain the surgeon had a ct scan done which showed that the femoral head pulled out of the mdm outer ball.Surgeon revised the patient to a cobalt chrome head and new mdm outer ball.
Additional Manufacturer Narrative
Catalog #; date of implant; date of explant.Additional information: date of birth; returned to manufacturer on.An event regarding dislocation involving a adm liner was reported.The event was not confirmed visual inspection: examination of the device with the material analysis engineer indicated "explantation damages were observed".Medical records received and evaluation: not performed as no medical records were provided.Review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Review indicated there have been no other similar events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to further investigate the event.If additional information becomes available, this investigation will be re-opened.
Event or Problem Description
The surgeon revised a tha patient due to dislocation.With continued pain the surgeon had a ct scan done which showed that the femoral head pulled out of the mdm outer ball.Surgeon revised the patient to a cobalt chrome head and new mdm outer ball.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6681004
• Report Number: 0002249697-2017-02099
• Device Sequence Number: 10817904
• Product Code: MEH
• UDI-Device Identifier: 04546540639028
• UDI-Public: 04546540639028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2020
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 54237501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR