MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #3 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6265-5103
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that the patient's left hip was revised.The patient had fallen 8 months prior to revision and sustained an acetabular fracture.Non-operative treatment failed, and the shell loosened.Once the patient was open, surgeon noted black tissue inside the patient.After removing the head from the stem, black material was seen inside the head and moderate trunnion wear was noted.The patient's hip construct was revised to a competitor hip.Rep confirmed there were no allegations against the revised liner.Rep confirmed there was no head dissociation.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture and wear involving citation stem that was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head and stem.Visual inspection of the photographs indicated that slight wear was observed on the stem trunnion.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that 'it was reported that the patient's left hip was revised.The patient had fallen 8 months prior to revision and sustained an acetabular fracture.Non-operative treatment failed, and the shell loosened.Once the patient was open, surgeon noted black tissue inside the patient.After removing the head from the stem, black material was seen inside the head and moderate trunnion wear was noted.The patient's hip construct was revised to a competitor hip.Rep confirmed there were no allegations against the revised liner.Additional information: rep confirmed there was no head dissociation.' a review of the provided medical records by a clinical consultant indicated: 'the operative note documents a revision surgery was performed.Unfortunately, in the documentation provided no intra-operative findings were noted.Revision tha surgery is confirmed.The cause for this revision tha cannot be determined from the limited documentation provided.' the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The reported citation stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc/capa.
Event or Problem Description
No new information.

• Brand Name: CITATION TMZF HA STEM #3 LEFT
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22165320
• Report Number: 0002249697-2025-00611
• Device Sequence Number: 9401757
• Product Code: LPH
• UDI-Device Identifier: 07613153074267
• UDI-Public: 07613153074267
• 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 Implanted Year: 2007
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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 Expiration Date: 08/30/2012
• Device Catalogue Number: 6265-5103
• Device Lot Number: 23051802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2007
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female