MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-140
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of right side tha components - accolade tmzf, 40mm standard femoral head and 40e acetabular insert due to dislocation of femoral head from stem.Replaced with 36e acetabular insert, #9x 13mm restoration ha stem 155mm, 36 +10mm v40 femoral head.Prior to surgery xray showed femoral head was dislocated from femoral stem.During surgery 40e insert found to be cracked, femoral stem was removed easily with no apparent bone in growth.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: the device was not returned however photographs were provided for review.A review of the provided photographs indicated recently explanted devices covered in blood and tissue.Trunnion wear observed consistent with loss of taper lock between the head and stem.-clinician review: the pre-op x-rays show a head stem dissociation.There is deformity of the trunnion with material loss and "penciling".The intra-op photographs show gross metallosis within the joint, confirmation of the trunnion deformity and severe poly wear in the superior aspect of the liner.The post -revision x-rays show a restoration ha stem and lateralized liner.Revision surgery for head stem dissociation and liner wear is confirmed.The root cause of this mechanical failure cannot be determined from this limited documentation." -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported the patient was revised due to disassociation of the head and stem.The device was not returned however photographs were provided for review.A review of the provided photographs indicated recently explanted devices covered in blood and tissue.Trunnion wear observed consistent with loss of taper lock between the head and stem.A review of medical records by the clinical consultant confirmed the event.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
Revision of right side tha components - accolade tmzf, 40mm standard femoral head and 40e acetabular insert due to dislocation of femoral head from stem.Replaced with 36e acetabular insert, #9x 13mm restoration ha stem 155mm, 36 +10mm v40 femoral head.Prior to surgery xray showed femoral head was dislocated from femoral stem.During surgery 40e insert found to be cracked, femoral stem was removed easily with no apparent bone in growth.

• Brand Name: V40 COCR LFIT HEAD 40MM/+0
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15400223
• Report Number: 0002249697-2022-01323
• Device Sequence Number: 14997281
• Product Code: JDI
• UDI-Device Identifier: 07613327032727
• UDI-Public: 07613327032727
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 6260-9-140
• Device Catalogue Number: 6260-9-140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male