MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#7L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6265-5207
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	09/20/2021
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.
Event or Problem Description
It was reported the patient's left hip was revised due to dissociation of the head from the stem.Intra-operatively, excessive trunnion wear a nd metallosis were noted.The stem, head, and competitor liner were revised to a restoration modular stem construct, a new femoral head, and another competitor liner.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving a citation stem that was mated with a lfit v40 cocr head was reported.The event was confirmed for disassociation based on medical records visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows biological material on the stem.Device history review: all 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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event, a dissociation of the head from the stem, was confirmed.A revision may be confirmed based on the photo of the explants.Severe trunnion wear was noted.Metallosis cannot be confirmed without additional medical records.The revision implants cannot be confirmed without additional medical records.Root cause: the root cause of the revision was trunnion wear and head dissociation.The root cause of the trunnion wear and head dissociation cannot ascertained without additional medical records and confirmation of the lot numbers of the implants.Conclusion: the reported citation stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported the patient's left hip was revised due to dissociation of the head from the stem.Intra-operatively, excessive trunnion wear a nd metallosis were noted.The stem, head, and competitor liner were revised to a restoration modular stem construct, a new femoral head, and another competitor liner.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: CITATION TMZF HA SHORT SIZE#7L
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 12633140
• Report Number: 0002249697-2021-01709
• Device Sequence Number: 4290694
• Product Code: LZO
• UDI-Device Identifier: 07613154316007
• UDI-Public: 07613154316007
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K053528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 03/31/2011
• Device Model Number: 6265-5207
• Device Catalogue Number: 6265-5207
• Device Lot Number: 16524202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• 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: 79 YR
• Patient Sex: Male