MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-50D
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient complained about her hip pain.After an x-ray, it was determined that the cup was loose.Upon explantation, it was discovered that there was no bony-ingrowth on the cup's surface.Update: "there were no allegations against the liner or biolox head.They were replaced in the revision surgery, but they worked as intended from the index surgery.".

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• 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: 9477338
• Report Number: 0002249697-2019-04033
• Device Sequence Number: 2852070
• Product Code: LPH
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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 Catalogue Number: 502-03-50D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/16/2019
• 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: 68 YR
• Patient Weight: 54