MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LFIT MORSE TAPER HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	01-3205
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Pseudotumor caused by armd from metal wear due to artificial joints.
Additional Manufacturer Narrative
Reported event: an event regarding altr and wear involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: damage consistent with explanation damage and the time the device stayed implanted.Clinician review: a review with a clinical consultant indicated" confirmation of event: i can confirm that the patient had a primary left total hip arthroplasty since an operation report albeit in japanese was provided with handwritten illustrations.I can also confirm that the patient had revision surgery also because i was able to look at an operation report also in japanese.I can also confirm that the patient had yet another revision also because i was able to look at a japanese written operation report.I cannot interpret details.Root cause analysis: the root cause of these events cannot be determined with certainty.Patient underwent a primary surgery, a revision surgery for osteolysis, a second revision surgery for dislocation and a third revision surgery for pseudotumor.The causes of these issues are multifactorial including surgical technique, the way the implants are positioned and aligned, as well as proper restoration of soft tissue tension in the thigh.Also to be considered is the proper preparation of the head and trunnion prior to and during insertion, patient factors including lifestyle, activity level and bmi, as well as implant factors." 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: a review with a clinical consultant indicated" confirmation of event: i can confirm that the patient had a primary left total hip arthroplasty since an operation report albeit in japanese was provided with handwritten illustrations.I can also confirm that the patient had revision surgery also because i was able to look at an operation report also in japanese.I can also confirm that the patient had yet another revision also because i was able to look at a japanese written operation report.I cannot interpret details.Root cause analysis: the root cause of these events cannot be determined with certainty.Patient underwent a primary surgery, a revision surgery for osteolysis, a second revision surgery for dislocation and a third revision surgery for pseudotumor.The causes of these issues are multifactorial including surgical technique, the way the implants are positioned and aligned, as well as proper restoration of soft tissue tension in the thigh.Also to be considered is the proper preparation of the head and trunnion prior to and during insertion, patient factors including lifestyle, activity level and bmi, as well as implant factors." 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
Pseudotumor caused by armd from metal wear due to artificial joints.

• Brand Name: LFIT MORSE TAPER HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20384196
• Report Number: 0002249697-2024-01370
• Device Sequence Number: 20819291
• Product Code: JDI
• UDI-Device Identifier: 07613327016178
• UDI-Public: 07613327016178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 01/31/2021
• Device Catalogue Number: 01-3205
• Device Lot Number: X67KXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2016
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian