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

Model Number	01-2200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.
Event or Problem Description
The patient underwent bipolar hip arthroplasty in 1996.The bipolar cup was broken, and dislocation occurred.Therefore, the bipolar cup and the inner head were removed and tha was performed on (b)(6) 2020.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 24-apr-2020 which indicated the returned devices were examined with the aid of a stereomicroscope at magnifications up to 50x.Nothing noteworthy was observed on the bipolar and femoral heads.A material analysis was conducted which concluded that the damage on the articulating surface of the insert was consistent with burnishing and delamination; which are common damage modes of uhmwpe.Yellow discoloration consistent with synovial fluid absorption was observed as well.Xrf showed that the femoral and bipolar head base alloys were consistent with their drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional analysis was not performed as the device was returned in damaged condition.Clinician review: not performed as no medical records were made available.Device history review: not performed as the provided lot code was not valid.Complaint history review: not performed as the provided lot code was not valid.Conclusions: it was reported that the was revised as the biploar cup was broken and dislocation occurred.The bipolar shell was received in two parts, the outer metallic part and inner poly part separate.A material analysis was conducted which concluded that the damage on the articulating surface of the insert was consistent with burnishing and delamination; which are common damage modes of uhmwpe.Yellow discoloration consistent with synovial fluid absorption was observed as well.Xrf showed that the femoral and bipolar head base alloys were consistent with their drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The event of dislocation can not be confirmed nor the exact cause of the event be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
The patient underwent bipolar hip arthroplasty in 1996.The bipolar cup was broken, and dislocation occurred.Therefore, the bipolar cup and the inner head were removed and tha was performed on (b)(6) 2020.

• Brand Name: LFIT MORSE TAPER HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9828617
• Report Number: 0002249697-2020-00522
• Device Sequence Number: 2886565
• Product Code: LWJ
• UDI-Device Identifier: 07613327016086
• UDI-Public: 07613327016086
• Combination Product (Y/N): N
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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 Model Number: 01-2200
• Device Catalogue Number: 01-2200
• Device Lot Number: 15102301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR