MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-336

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Reaction (2414)

Event Date 11/30/2018

Event Type  Injury  

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.Device not returned.

Event Description

It was reported that the patient's left hip was revised due to the neck of the stem breaking off.Intra-operatively, black tissue was observed.Patient was revised to a restoration modular stem construct with a 28 metal head and 48 mdm liner with insert.

Event Description

It was reported that the patient's left hip was revised due to the neck of the stem breaking off.Intra-operatively, black tissue was observed.Patient was revised to a restoration modular stem construct with a 28 metal head and 48 mdm liner with insert.

Manufacturer Narrative

Reported event: an event regarding disassociation and corrosion involving a metal head was reported.The event was confirmed through material analysis of the returned product.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 04 april 2019 which indicated: damage was observed on the head, likely from interacting with the trunnion of the accolade stem.A step is observed at the proximal end of the taper.A material analysis has been performed.The report concluded: damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock.The trunnion of the stem had fractured, with the fracture initiating in fatigue and the final fracture occurring in overload.A majority of the stem trunnion had already been destroyed by the loss of taper lock and articulation of taper and trunnion.The intergranular fracture morphologies were observed near the location of final fracture on the trunnion.Eds showed the stem was consistent with astm f1813 alloy.Burnishing, scratching and third-body indentations were observed on the insert, which are common damage modes of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.Clinician review: not performed as the provided records were insufficient to complete a medical review.The clinician stated: need revision operative reports, office/clinical reports, serial x-rays.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Lot specific voluntary recall v40 - recall -249697-05/07/2018-003r was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• 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: 8204662
• MDR Text Key: 131702342
• Report Number: 0002249697-2018-04185
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

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: 03/31/2016
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MJNN6M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86