MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL FEM COMP STD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	64951001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It appears that the patient received a gmrs hip replacement in mid-2024.The patient complains of muscle pain and muscle tension, among other issues.The patient is concerned that he is allergic to the implan.T.
Additional Manufacturer Narrative
The following devices were also listed in this report: mrs fem stem w/o body 13x127mm; cat# 64853113; lot# 269018d1.Gmrs extension piece 50mm; cat# 64956050; lot# bedcu.Alumina v40-femoral head 28mm, +4mm nk; cat# 6565-0-228; lot# 17420551.Uhr bipolar 28x52mm; cat# uh1-52-28; lot# 2m71pv.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: PROXIMAL FEM COMP STD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21320256
• Report Number: 0002249697-2025-00148
• Device Sequence Number: 15576898
• Product Code: LPH
• UDI-Device Identifier: 07613327048704
• UDI-Public: 07613327048704
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 64951001
• Device Lot Number: YR67A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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: Other
• Patient Sex: Male