MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40(TM). FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6364-2-036
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.
Event or Problem Description
It was reported through the submission of an implant sheet that patient's right hip was revised.
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: not performed as the reported device was not returned for evaluation.Clinician review: a medical review was not performed because insufficient information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: it was reported that patient was revised due to dislocation.The event could not be confirmed nor the root cause determined as sufficient information was not provided.Further information such as return of device, operative reports, x-rays, histopathology reports, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
It was reported through the submission of an implant sheet that patient's right hip was revised.Update- patient was revised due to dislocation.Patient's weight (b)(6) pounds.

• Brand Name: V40(TM). FEMORAL 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: 7203649
• Report Number: 0002249697-2018-00202
• Device Sequence Number: 1277409
• Product Code: LPH
• UDI-Device Identifier: 07613153121992
• UDI-Public: 07613153121992
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 09/14/2021
• Device Catalogue Number: 6364-2-036
• Device Lot Number: G5816422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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: 59