MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1235-2-562
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient's thigh was painful, surgery to replace with larger stem and shorter head and liner.X-ray confirms loosening of the acetabulum and shows radiolucency around the shell.
Additional Manufacturer Narrative
An event regarding pain and loosening was reported.The event was confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.The provided medical information was submitted to a consulting clinician who confirmed the loosening of the acetabulum and radiolucency around the shell with provided x-rays but deemed the information insufficient and rejected it for a medical review.Review of oracle transactions indicate the devices were manufactured and accepted into finished goods.There have been no other events for the lot referenced.The provided medical information was submitted to a consulting clinician who confirmed the loosening of the acetabulum and radiolucency around the shell with provided x-rays but deemed the information insufficient and rejected it for a medical review.Further information such as primary and revision operative reports, past/clinical medical history, serial x-rays and examination of explanted components are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Patient's thigh was painful, surgery to replace with larger stem and shorter head and liner.X-ray confirms loosening of the acetabulum and shows radiolucency around the shell.

• Brand Name: RESTORATION (TM) ADM CUP W/HA
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6461869
• Report Number: 0002249697-2017-01151
• Device Sequence Number: 407001
• Product Code: LPH
• UDI-Device Identifier: 04546540638793
• UDI-Public: (01)04546540638793(11)160322(17)210224(10)G5951830
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: 02/24/2021
• Device Model Number: 1235-2-562
• Device Catalogue Number: 1235-2-562
• Device Lot Number: G5951830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 12/27/2017
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 113