MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK ACCOLADE TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-0230

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/22/2022

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.H3 other text : device not returned to the manufacturer.

Event Description

It is reported by counsel that claimant underwent right tha on (b)(6) 2008, and was implanted with a accolade tmzf hip stem and a lfit anatomic v40 femoral head.She was revised on (b)(6) 2022, allegedly due to head disassociation.

Manufacturer Narrative

Reported event: an event regarding disassociation involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was not confirmed.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: no medical records were received for review with a clinical consultant device history review: a review of the device history records could not be performed as after an extensive search for this windchill, archive logs and boxes retrieved from iron mountain, the dhr could not be located.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the reported accolade 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.H3 other text : device not returned.

Event Description

It is reported by counsel that claimant underwent right tha on (b)(6)2008, and was implanted with a accolade tmzf hip stem and a lfit anatomic v40 femoral head.She was revised on (b)(6) 2022, allegedly due to head disassociation.

• Brand Name: ACCOLADE TMZF HIP STEM #2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 18098606
• MDR Text Key: 327699097
• Report Number: 0002249697-2023-01373
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510549
• UDI-Public: 04546540510549
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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 Catalogue Number: 6020-0230
• Device Lot Number: 4499202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female