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 Codes	Injury (2348); Reaction (2414)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
As reported: "patient underwent left hip revision surgery to replace implanted lfit v40 44mm/-4 femoral head and 44g x3 neutral acetabular liner.Surgeon claims trunnion and inside of explanted femoral head contained noticeable black debris following explant.Surgeon does not have concerns about the functionality of the liner.".
Event or Problem Description
As reported: "patient underwent left hip revision surgery to replace implanted lfit v40 44mm/-4 femoral head and 44g x3 neutral acetabular liner.Surgeon claims trunnion and inside of explanted femoral head contained noticeable black debris following explant.Surgeon does not have concerns about the functionality of the liner.".
Additional Manufacturer Narrative
An event regarding fretting and corrosion involving a metal head was reported.The event was confirmed through material analysis report (mar).Method & results -product evaluation and results: the damage present on the female taper of head is consistent with contact against hip stem trunnion.Elemental analysis showed that the head was consistent with the drawing (astm f1537).The debris was consistent with a corrosion product, biological material, an oxide, and material transfer from a hip stem.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that noticeable black debris was noticed on the trunnion and inside of explanted femoral head.This was confirmed to be fretting debris and corrosion through material analysis report (mar).The mar report indicated that the damage present on the female taper of head is consistent with contact against hip stem trunnion.Elemental analysis showed that the head was consistent with the drawing (astm f1537).The debris was consistent with a corrosion product, biological material, an oxide, and material transfer from a hip stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, 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: 8864284
• Report Number: 0002249697-2019-02750
• Device Sequence Number: 13983147
• Product Code: JDI
• UDI-Device Identifier: 07613327032710
• UDI-Public: 07613327032710
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 01/31/2019
• Device Catalogue Number: 6260-9-044
• Device Lot Number: MMR6T4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 84