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

Model Number	6265-5104
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Rep received a text message from a surgeon with a picture of an explanted citation stem.Surgeon is asking if the device was part of a recall.Per response: "¿the reason for revision is a titanium adverse local tissue reaction.It was a ceramic head on a polyethylene liner, she had multiple head/liner and cup revisions since the original surgery, the stem was the only original component.¿ "no other implant information was provided patient had previous surgeries performed at different hospital.".
Additional Manufacturer Narrative
Reported event: an event regarding altr involving a citation stem was reported.The event was not confirmed for altr.Method & results:  -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a citation stem and a biolox head were implanted in 2010.The patient had multiple problems with the hip and ultimately underwent a revision surgery for adverse local tissue reaction, abductor insufficiency and instability.The patient had other revision surgeries but these were only documented in the pi report.Event confirmation: a revision surgery where a citation stem was explanted can be confirmed.A recall of said device cannot be confirmed.Root cause: the root cause of the revision surgery was adverse local tissue reaction, abductor insufficiency and instability.The root cause of these diagnoses cannot be ascertained.-device 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.Conclusion: a clinician review of the provided medical records states the following: "a citation stem and a biolox head were implanted in 2010.The patient had multiple problems with the hip and ultimately underwent a revision surgery for adverse local tissue reaction, abductor insufficiency and instability.The patient had other revision surgeries but these were only documented in the pi report.Event confirmation: a revision surgery where a citation stem was explanted can be confirmed.A recall of said device cannot be confirmed.Root cause: the root cause of the revision surgery was adverse local tissue reaction, abductor insufficiency and instability.The root cause of these diagnoses cannot be ascertained." the event could not be confirmed as insufficient information was provided.Further information such as device lot identification and return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Rep received a text message from a surgeon with a picture of an explanted citation stem.Surgeon is asking if the device was part of a recall.Per response: "¿the reason for revision is a titanium adverse local tissue reaction.It was a ceramic head on a polyethylene liner, she had multiple head/liner and cup revisions since the original surgery, the stem was the only original component.¿ "no other implant information was provided patient had previous surgeries performed at different hospital.".

• 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: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17064126
• Report Number: 0002249697-2023-00621
• Device Sequence Number: 6105291
• Product Code: LPH
• UDI-Device Identifier: 07613153074274
• UDI-Public: 07613153074274
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 07/31/2015
• Device Model Number: 6265-5104
• Device Catalogue Number: 6265-5104
• Device Lot Number: 33621101
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female