MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #6 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6265-5116
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/15/2022
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.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient fell and head dissociation was diagnosed (unknown which one caused the other).Intra-operatively, trunnion wear was noted.The stem, head, and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep confirmed he will provide all pictures and documents available to him from the hospital and surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a citation stem which was mated with a lfit v40 cocr head was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated that the trunnion of the stem was severely worn.Damage is consistent with the loss of taper lock.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.Clinician review: no medical records were provided for review with 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 lot referenced.Conclusions: it was reported that the patient was revised due to disassociation of the head from stem.The event was confirmed by examination of the returned devices.Visual inspection indicated that damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc pr and capa pr.No further investigation for this event is required at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient fell and head dissociation was diagnosed (unknown which one caused the other).Intra-operatively, trunnion wear was noted.The stem, head, and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep confirmed he will provide all pictures and documents available to him from the hospital and surgeon.Spoke with patient's wife who called patient hotline who was provided the product inquiry by the surgeon.Patient was playing golf and fell on right "buttocks" and two weeks later started feeling "something", went to surgeon and was immediately scheduled for surgery.She indicated revision required removal of "metal fragments".She indicated surgeon stated parts are part of a recall.Patient wants to know if confirm if parts subject to a recall.Patient is seeking compensation.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient fell and head dissociation was diagnosed (unknown which one caused the other).Intra-operatively, trunnion wear was noted.The stem, head, and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep confirmed he will provide all pictures and documents available to him from the hospital and surgeon.Spoke with patient's wife who called patient hotline who was provided the product inquiry by the surgeon.Patient was playing golf and fell on right "buttocks" and two weeks later started feeling "something", went to surgeon and was immediately scheduled for surgery.She indicated revision required removal of "metal fragments".She indicated surgeon stated parts are part of a recall.Patient wants to know if confirm if parts subject to a recall.Patient is seeking compensation.Update 15-feb-2023: this pi is for the right hip.Patient was revised to remove "metal fragments" and recall inquiry.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a citation stem which was mated with a lfit v40 cocr head was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated that the trunnion of the stem was severely worn.Damage is consistent with the loss of taper lock.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.Clinician review: no medical records were provided for review with 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 lot referenced.Conclusions: it was reported that the patient was revised due to disassociation of the head from stem.The event was confirmed by examination of the returned devices.Visual inspection indicated that damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc pr and capa pr.No further investigation for this event is required at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CITATION TMZF HA STEM #6 RIGHT
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15154612
• Report Number: 0002249697-2022-01141
• Device Sequence Number: 20182175
• Product Code: LPH
• UDI-Device Identifier: 07613153074397
• UDI-Public: 07613153074397
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2023

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: 04/30/2013
• Device Model Number: 6265-5116
• Device Catalogue Number: 6265-5116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 02/17/2023
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 11/02/2022; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2008
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 125 KG