MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #8 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6265-5108
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	09/06/2022
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.Device not returned to the manufacturer.
Event or Problem Description
Wife reported her husband had a revision of the left hip on (b)(6) 2022 due to the "two metals being worn down to fine pencil tips".Primary surgery was done in (b)(6) 2007.
Event or Problem Description
Wife reported her husband had a revision of the left hip on (b)(6) 2022 due to the "two metals being worn down to fine pencil tips".Primary surgery was done on (b)(6) 2007.Update: per patient medical records, it was indicated that the patient was revised due to disassociation of the head from the stem, fracture of the femoral stem trunnion, metallosis and osteolysis, destruction of abductors, heterotopic ossification and fracture of the greater trochanter whereby the stem, head and liner were explanted and the patient was converted to a restoration modular construct with dall miles grip plate and cabling for fixation.It was also reported that the shell was slightly more vertical than ideal but removal would have caused significant bone loss, so it was left implanted.During revision surgery, the following were performed: "debridement of chronic metallic wear debris and osteolysis," "open reduction internal fixation left greater trochanter fracture," and "resection of heterotopic ossification." despite the reported proximal bone erosions, the femoral stem was reported to be well-fixed and removal was intensive.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and disassociation involving a citation stem that was mated with a lfit v40 cocr head was reported.The event was confirmed via clinician review of provided medical records.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: the patient underwent a tha with a citation tmzf stem matched to a v40 lfit 36 mm head in 2007.In 2022, he had a catastrophic failure of the femoral stem with a trunnion fracture.He underwent a revision tha.Event confirmation: the event, a revision for fracture of the femoral stem was confirmed.Root cause: the root cause of the revision was fracture of the femoral stem.The root cause of the stem fracture cannot be stated." 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: 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.

• Brand Name: CITATION TMZF HA STEM #8 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; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16590146
• Report Number: 0002249697-2023-00289
• Device Sequence Number: 4937340
• Product Code: LPH
• UDI-Device Identifier: 07613153074311
• UDI-Public: 07613153074311
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 09/30/2009
• Device Model Number: 6265-5108
• Device Catalogue Number: 6265-5108
• Device Lot Number: 10000301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2004
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White