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

Device Problems Degraded (1153); Material Erosion (1214); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Joint Laxity (4526); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 09/06/2022

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 311752489
• Report Number: 0002249697-2023-00289
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613153074311
• UDI-Public: 07613153074311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White