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 Pain (1994)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray shows a dissociated left tha with remodeling and material loss on the trunnion.The photograph of the explanted stem shows remodeling and material loss on the trunnion.The intra-op photograph again shows remodeling and material loss on the trunnion.The ap hip x-ray shows a right tha with remodeling and material loss on the trunnion.Neither x-ray was dated or marked with laterality so although they are similar in appearance i can not be sure if they are of the same patient.It is confirmed that a patient had dissociation of atha with marked trunnionosis and material loss with deformity.The root cause of the trunnionosis cannot be determined from the limited documentation provided.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to disassociation of the femoral head from the stem.A review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray shows a dissociated left tha with remodeling and material loss on the trunnion.The photograph of the explanted stem shows remodeling and material loss on the trunnion.The intra-op photograph again shows remodeling and material loss on the trunnion.The ap hip x-ray shows a right tha with remodeling and material loss on the trunnion.Neither x-ray was dated or marked with laterality so although they are similar in appearance i can not be sure if they are of the same patient.It is confirmed that a patient had dissociation of atha with marked trunnionosis and material loss with deformity.The root cause of the trunnionosis cannot be determined from the limited documentation provided." 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

Primary tha surgery was done at (b)(6) 2011.Unable to walk due to broken implant.Revision surgery is scheduled at (b)(6) 2023.Updated information: a month ago, he staggered and fell on a fishing boat, and since then he has been feeling discomfort from his hip to his right hip.(b)(6) when i got up from my chair, my legs felt wobbly.When he lay down and tried to get up, he developed pain in his right hip and had difficulty moving.As a result of a visit to the primary care physician, a tha dislocation was found and the patient was transferred to the main hospital.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18222707
• MDR Text Key: 329192847
• Report Number: 0002249697-2023-01466
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173499
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MKE1R7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG