MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REST HA -5 RED NK 205MM STRT STM 11X17MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC

Model Number	S-2652-1117
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	02/22/2023
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.H3 other text : device not returned.
Event or Problem Description
It was reported that there was apparent trunnionosis discovered after revision.It was further reported that "patient reported pain in groin/ buttocks area.Surgeon revised acetabulum and noticed what looked to be trunnionosis on stem and head.Deep grove of articulating surface of liner was noticed and wondered where that could have come from.Discolouration (yellow tinge) of liner is a concern as well.No infection was present just a lot of inflammation.".

• Brand Name: REST HA -5 RED NK 205MM STRT STM 11X17MM
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16589078
• Report Number: 0002249697-2023-00286
• Device Sequence Number: 5703751
• Product Code: MEH
• UDI-Device Identifier: 07613327019483
• UDI-Public: 07613327019483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 05/31/2022
• Device Model Number: S-2652-1117
• Device Catalogue Number: S-2652-1117
• Device Lot Number: DN7YK7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male