MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM -4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6260-9-028
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding periprosthetic fracture of the pelvis involving a custom peri-acetabular reconstruction prosthesis was reported.Clinician review of the medical records provided indicated that a disassociation between the stem taper and metal head component had also occurred.The event was confirmed based on review of the medical records provided by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned, it remains implanted.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: beyond the reported iliac wing fracture, there is the problem of dislocation between femoral component and pelvic prosthesis with apparent disassociation between femoral head and angle adapter to the femoral stem.This instability problem is likely caused by the lack of soft tissue stabilising structures around the connection between femoral and pelvic components.[.] these problems are to a certain degree unavoidable given the requirements for radical resection of malignant tumours and are thus procedure-related even though the surgeon can¿t help the problem.Device history review: the device was manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar reported events for the reported lot.Conclusion: based on clinician review of the medical records provided the disassociation between the stem taper and the metal head component was confirmed however it is not possible to determine the exact cause of the event.Clinician review indicated beyond the reported iliac wing fracture, there is the problem of dislocation between femoral component and pelvic prosthesis with apparent disassociation between femoral head and angle adapter to the femoral stem.This instability problem is likely caused by the lack of soft tissue stabilising structures around the connection between femoral and pelvic components.[.] these problems are to a certain degree unavoidable given the requirements for radical resection of malignant tumours and are thus procedure-related even though the surgeon can¿t help the problem.Further information such as device evaluation would be required to further investigate this event to determine a definitive root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Rep reported "patient's pelvis fractured above the saddle during physical therapy and will have to be revised.Beyond the reported iliac wing fracture, there is the problem of dislocation between femoral component and pelvic prosthesis with apparent disassociation between femoral head and angle adapter to the femoral stem.".

• Brand Name: 28MM -4 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7409667
• Report Number: 0002249697-2018-01062
• Device Sequence Number: 13598496
• Product Code: LPH
• UDI-Device Identifier: 07613327012996
• UDI-Public: 07613327012996
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 05/30/2022
• Device Catalogue Number: 6260-9-028
• Device Lot Number: 59622804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/09/2018
• 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: 63 YR
• Patient Weight: 85