MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-021; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-1-021
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain.A 21 +0 restoration modular cone body and 36 +5 biolox v40 head were revised to a 25 +0 body and new femoral head.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: 21MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-021
• 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: 10725266
• Report Number: 0002249697-2020-02220
• Device Sequence Number: 1679539
• Product Code: LPH
• UDI-Device Identifier: 04546540641076
• UDI-Public: 04546540641076
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 11/30/2018
• Device Model Number: 6276-1-021
• Device Catalogue Number: 6276-1-021
• Device Lot Number: 45411501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: 52 YR