MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-48C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Cancer (3262)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device evaluated by manufacturer? not available.
Event or Problem Description
The patient presented with protrusio of the acetabular cup requiring revision.The patient had a history of cancer.We used a bone tamp to remove the femoral head and mdm insert.We then used the mdm liner removal instrument to take the liner out of the cup.We then took the screws out of the cup and used the ez out acetabular extractor to take the cup out.We replaced the cup with a gap cup and exeter cemented cup with a 32 head and found the joint to be stable.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM
• 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: 9957278
• Report Number: 0002249697-2020-00743
• Device Sequence Number: 2416188
• Product Code: LPH
• UDI-Device Identifier: 07613327040111
• UDI-Public: 07613327040111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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: 05/31/2021
• Device Model Number: 502-03-48C
• Device Catalogue Number: 502-03-48C
• Device Lot Number: XV6KJ7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/14/2020
• 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: 66 YR