MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#3R; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6265-5213
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Insufficient Information (4580)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: pt.Reported; she had her initial hip replacement on (b)(6) 2010.She experienced a lot of pain and it started to dislocate after 11 years.On (b)(6) 2021, she had her 1st revision for dislocation.A second hip replacement which was also a stryker product was implanted.She had complaints about it from the moment it was put in.It just wasn't comfortable it didn't feel right.There was a lot of pain for three years and she was told everything was fine there was nothing wrong with the product.On (b)(6) 2025, she went for a second opinion and it was discovered that the ball was wearing on the stem causing a ridge to develop, the screw which held the ball was broken, she had severe bone loss, and metal shavings basically fallen off into her body.The second revision which was an emergency hip replacement was performed (on (b)(6) 2025) with non-stryker implants.It was discovered she had severe bone loss.Per the orthopedic surgeon; it looked like a bomb had gone off on her leg and the surgery was intense.This has left her relying on some sort of walking assistance device.Pt.Further stated her quality of life has completely changed; she's been in pain and suffering for the last five years.2nd revision.
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.

• Brand Name: CITATION TMZF HA SHORT SIZE#3R
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25659003
• Report Number: 0002249697-2026-00556
• Device Sequence Number: 14852160
• Product Code: LZO
• UDI-Device Identifier: 07613154316069
• UDI-Public: 07613154316069
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 01/31/2015
• Device Catalogue Number: 6265-5213
• Device Lot Number: 32141601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2010
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 58 KG