MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM +5 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-236

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ambulation Difficulties (2544)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation involving a metal head was reported.The events was confirmed via med review and review of the provided photographs.Method & results: product evaluation and results: visual inspection: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral head with signs of implantation/explanation damage.Clinician review: a review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient underwent a primary total hip arthroplasty as described above since i was able to review and x-ray showing the implant.I can also confirm that the patient's developed a head neck disassociation with loss of material on the trunnion also because i was able to see the explanted prosthesis.Some blackened material was also noted within the bore of the femoral head.The root causes of head neck disassociation with loss of material of the trunnion and blackened material within the border of the femoral head are multifactorial including surgical technique, especially in the preparation and insertion of the femoral head onto the trunnion, patient factors including activity level and bmi, and implant factors." product history review: not performed as the lot number was not provided.Complaint history review: not performed as the lot number was not provided.Conclusions: it was reported that the patient was revised due to disassociation of the femoral head from the stem.The device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral head with signs of implantation/explanation damage.Aa review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient underwent a primary total hip arthroplasty as described above since i was able to review and x-ray showing the implant.I can also confirm that the patient's developed a head neck disassociation with loss of material on the trunnion also because i was able to see the explanted prosthesis.Some blackened material was also noted within the bore of the femoral head.The root causes of head neck disassociation with loss of material of the trunnion and blackened material within the border of the femoral head are multifactorial including surgical technique, especially in the preparation and insertion of the femoral head onto the trunnion, patient factors including activity level and bmi, and implant factors." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

It was reported that the patient's right hip was revised due to head dissociation.Intra-operatively, excessive wear was noted of the trunnion.The stem, head and liner were revised to a competitor stem, head, and dual mobility poly with a stryker mdm liner.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: V40 COCR LFIT HEAD 36MM +5 OFFSET
• Type of Device: 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19015820
• MDR Text Key: 339063885
• Report Number: 0002249697-2024-00531
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 6260-9-236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 64 KG