MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initially an event regarding a periprosthetic fracture involving a metal head was reported.But provided medical records alleged disassociation.The event was not confirmed.Method & results: device evaluation and results: not performed as device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "no clinical or pmh, no patient demographics, no imaging studies, no primary tha op report or date of surgery, no examination of explanted components.The event description states "periprosthetic fracture" but the revision op report describes a prosthetic disassociation and erosion.Based upon the information available for review, no creation of a medical report is possible for this case." device history review: all 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 reported lot.Conclusions: clinician review indicated that the event description states "periprosthetic fracture" but the revision op report describes a prosthetic disassociation and erosion.Based upon the information available for review, no creation of a medical report is possible for this case.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x-rays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Patient presented with periprosthetic hip fracture.Revision was done.*update on 10-jul-2020: "(b)(6) 2017 op note - revision left total hip  pre/post-op diagnosis "failure left total hip replacement" gen anesthesia, "extended trochanteric osteotomy.Significant titanium debris.Femoral stem well fixed.Trunnion eroded.Beaklike in shape.Head disassociated.Acet.Shell well fixed." per clinician review comment: "the event description states "periprosthetic fracture" but the revision op report describes a prosthetic disassociation and erosion.Based upon the information available for review, no creation of a medical report is possible for this case.".

• Brand Name: 32MM +4 V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10375815
• Report Number: 0002249697-2020-01621
• Device Sequence Number: 14369631
• Product Code: JDI
• UDI-Device Identifier: 07613327012903
• UDI-Public: 07613327012903
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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 Expiration Date: 03/31/2010
• Device Model Number: 6260-5-232
• Device Catalogue Number: 6260-5-232
• Device Lot Number: 12730601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/06/2020
• 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: 51 YR