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

Catalog Number 6260-9-236

Device Problem Scratched Material (3020)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Revision hip due to pain.Primary hip replacement (b)(6) 2018.Polyethylene liner found to have small metal looking scratches on inner surface.Metal head has scratched surface too.Bone screws were also loose and cup had very minimal on growth of bone.All acetabular components removed.Acetabulum revised using competitor prosthesis.

Event Description

Revision hip due to pain.Primary hip replacement february 2018 polyethylene liner found to have small metal looking scratches on inner surface.Metal head has scratched surface too.Bone screws were also loose and cup had very minimal on growth of bone.All acetabular components removed.Acetabulum revised using competitor prosthesis.

Manufacturer Narrative

An event regarding damage involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted metal head but no evidence of damage could be detected from the provided photographs.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.A review of the provided medical records and x-rays by a clinical consultant indicated: "provided x-ray does not confirm the reported event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." 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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and return of the device are needed to fully investigate the event.If further information becomes available and/or the product is returned, this investigation will be re-opened.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8443209
• MDR Text Key: 139539499
• Report Number: 0002249697-2019-01412
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 6260-9-236
• Device Lot Number: DP0AR5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention