MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-044
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot specific voluntary recall 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 (b)(6) 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.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.
Event or Problem Description
Sales rep reported that he had been made aware of a revision surgery of an accolade stem.
Event or Problem Description
Sales rep reported that he had been made aware of a revision surgery of an accolade stem.
Additional Manufacturer Narrative
Lot specific voluntary recall 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.An event regarding revision surgery involving an v40 metal head was reported.The reason for the revision surgery was not confirmed.Method & results: device evaluation and results:damage consistent with the explantation process was observed on the distal side of the head.Images were taken of the inner taper of the head where debris was observed and collected on a pin mount.Damage present on the surface of the taper is consistent with interaction between the head and trunnion.Eds showed the head was consistent with astm f1537 and the debris on the interior taper was consistent with an oxide, a corrosion process, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: damage consistent with the explantation process was observed on the distal side of the head.Images were taken of the inner taper of the head where debris was observed and collected on a pin mount.Damage present on the surface of the taper is consistent with interaction between the head and trunnion.Eds showed the head was consistent with astm f1537 and the debris on the interior taper was consistent with an oxide, a corrosion process, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including reason for revision, operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: V40 COCR LFIT HEAD 44MM/-4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8404109
• Report Number: 0002249697-2019-01277
• Device Sequence Number: 1976127
• Product Code: JDI
• UDI-Device Identifier: 07613327032710
• UDI-Public: 07613327032710
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 6260-9-044
• Device Lot Number: MJJJD6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention