MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #5 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6265-5105
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	08/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2011 and was revised on (b)(6) 2018.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue and excessive levels of cobalt and chromium in his blood.
Additional Manufacturer Narrative
Reported event: an event regarding altr/abnormal ion level and corrosion involving a citation stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "assessment: revision surgery was performed for "elevated metal levels" and a positive mri associated with pain in a left hip that had been implanted with a lfit v40 cobalt chrome head and citation stem.No preoperative or postoperative medical data were provided for review.No radiographs were provided for review.Laboratory studies and mri reports were not provided for review.Confirmation: a revision of the left hip surgery can be confirmed.Elevated metal levels and mri findings cannot be confirmed.Corrosion and metal response that were noted at the time of revision surgery but cannot be confirmed via pathology reports." -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 lot referenced.Conclusions: it was reported that the patient was revised due to excessive levels of cobalt and chromium, altr, and corrosion at the stem-head interface.A review of the provided medical records by a clinical consultant indicated: "assessment: revision surgery was performed for "elevated metal levels" and a positive mri associated with pain in a left hip that had been implanted with a lfit v40 cobalt chrome head and citation stem.No preoperative or postoperative medical data were provided for review.No radiographs were provided for review.Laboratory studies and mri reports were not provided for review.Confirmation: a revision of the left hip surgery can be confirmed.Elevated metal levels and mri findings cannot be confirmed.Corrosion and metal response that were noted at the time of revision surgery but cannot be confirmed via pathology reports." 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 through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2011 and was revised on (b)(6) 2018.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue and excessive levels of cobalt and chromium in his blood.Update per medical records received: corrosion observed at the stem-head interface intraoperatively.Adverse local tissue reaction also reported.The stem was not revised as it was observed to be well-fixed.

• Brand Name: CITATION TMZF HA STEM #5 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7975874
• Report Number: 0002249697-2018-03420
• Device Sequence Number: 11201490
• Product Code: LPH
• UDI-Device Identifier: 07613153074281
• UDI-Public: 07613153074281
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2016
• Device Catalogue Number: 6265-5105
• Device Lot Number: 36445202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2011
• 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: 73 YR
• Patient Sex: Male