MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #4 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6265-5104
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Reaction (2414); Metal Related Pathology (4530)
Date of Event	09/16/2010
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.Not available.
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) 2010.It is further alleged that he suffered injuries as a result of implantation of the device at issue, excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head.
Additional Manufacturer Narrative
Device information added.An event regarding alleged excessive levels of chromium and cobalt involving a citation stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-medical records received and evaluation: not performed as no medical records received for evaluation.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause as insufficient information was received.If further information and/or the device becomes available this investigation 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) 2010.It is further alleged that he suffered injuries as a result of implantation of the device at issue, excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head.
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) 2010.It is further alleged that he suffered injuries as a result of implantation of the device at issue, excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head.Additional information per medical records received from legal, "we disengaged the head and we were able to talk to the trunnion anterosuperiorly while we assess the acetabulum.".
Additional Manufacturer Narrative
Reported event: an event regarding regarding infection and abnormal ion level involving a citation stem was reported.The event of infection was confirmed through medical review.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of provided medical records with a clinical consultant indicated: the operative report documents that an i and d with head and liner exchange for peri-prosthetic joint infection (pji) was completed on 5/9/19.No evidence was provided documenting elevated serum cobalt and chromium levels nor the need for revision.I and d with head and liner exchange for peri-prosthetic joint infection (pji) is confirmed.The root cause of the infection cannot be determined with the documentation provided.The operative report documents that an i and d with head and liner exchange for peri-prosthetic joint infection (pji) was completed on 5/9/19.No evidence was provided documenting elevated serum cobalt and chromium levels nor the need for revision.I and d with head and liner exchange for peri-prosthetic joint infection (pji) is confirmed.The root cause of the infection cannot be determined with the documentation provided." -device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: a review of provided medical records with a clinical consultant indicated: the operative report documents that an i and d with head and liner exchange for peri-prosthetic joint infection (pji) was completed on 5/9/19.No evidence was provided documenting elevated serum cobalt and chromium levels nor the need for revision.I and d with head and liner exchange for peri-prosthetic joint infection (pji) is confirmed.The root cause of the infection cannot be determined with the documentation provided.The operative report documents that an i and d with head and liner exchange for peri-prosthetic joint infection (pji) was completed on 5/9/19.No evidence was provided documenting elevated serum cobalt and chromium levels nor the need for revision.I and d with head and liner exchange for peri-prosthetic joint infection (pji) is confirmed.The root cause of the infection cannot be determined with the documentation provided."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.The following devices were also listed in this report: 6.5 cancellous bone screw 35mm; cat# 2030-6535-1; lot# mjm1tt trident 10° crossfire insert 36 mm id; cat# 621-10-36e; lot# 15hef4 trident hemispherical cluster hole shell; cat# 502-11-52e; lot# 33754201 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: CITATION TMZF HA STEM #4 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7880763
• Report Number: 0002249697-2018-02891
• Device Sequence Number: 16609831
• Product Code: LPH
• UDI-Device Identifier: 07613153074274
• UDI-Public: 07613153074274
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024
• 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: 04/30/2015
• Device Catalogue Number: 6265-5104
• Device Lot Number: 32940001
• 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: 08/21/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 08/19/2024
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/15/2018; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2010
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male