MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-144
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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 or Problem Description
As reported: "head detached from trunnion.Trunnion wore out by metal head." orthopedic consultation provided by the rep notes patient complaint of pain starting approximately 2017 eventually becoming severe.Patient "turned suddenly and felt immediate pain and pop right inguinal [groin] region" with a finding of a fracture of the stem at the head neck junction and stem migration.Operative report for revision reports".A significant amount of metal stained synovial fluid.Also significant metal stained synovitis.Femoral stem was noted to be grossly loose with significant osteolysis about the proximal femur".Patient was revised to a restoration modular stem construct, v40 28 -2.7 ceramic head, mdm/adm liner construct, and a competitor cable placed "to help prophylax against periprosthetic fracture" (no bone fractures are noted in the operative report).Rep provided the orthopedic consultation visit, revision operative report, pre- and post-revision x-rays and explant pictures.
Additional Manufacturer Narrative
An event regarding disassociation and metallosis involving a metal head mated with an accolade stem was reported.A review by a clinician of the provided x-rays confirmed disassociation.Review of the provided revision operative report indicates metal stained synovitis (metallosis).Method & results: product evaluation and results: the device was not returned but photos of the explant were provided.There is some staining/marking around the mating section of the head.It cannot be confirmed what the apparent staining/marking is.Medical records received and evaluation: x-ray printouts available for review include a series dated (b)(6) 2019, which is an ap of the right hip demonstrating an uncemented right total hip arthroplasty with one screw in the acetabulum.The stem and acetabular shell are in nominal position and the head is in the acetabulum but the trunnion is disassociated and dislocated from the head.There is no primary operative report, no patient¿s weight, and no serial x-rays or follow-up for the right total hip arthroplasty until (b)(6) 2019.No examination of explanted components is available for review.The nine-day delay from admission to surgery likely resulted in the metalosis noted at revision surgery due to abrasion of the disassociated trunnion against the femoral head and acetabular rim.Based upon the information available for review, no determination can be made for the loss of locking of the head/trunnion interface, which occurred twelve years status-post implantation.If additional information is received, this report will be updated.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 were no other events for the lot provided.Conclusions: based upon the information available for review, no determination can be made for the loss of locking of the head/trunnion interface, which occurred twelve years status-post implantation.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of nc and capa.No further investigation is required.
Event or Problem Description
As reported: "head detached from trunnion.Trunnion wore out by metal head." orthopedic consultation provided by the rep notes patient complaint of pain starting approximately 2017 eventually becoming severe.Patient "turned suddenly and felt immediate pain and pop right inguinal [groin] region" with a finding of a fracture of the stem at the head neck junction and stem migration.Operative report for revision reports".A significant amount of metal stained synovial fluid.Also significant metal stained synovitis.Femoral stem was noted to be grossly loose with significant osteolysis about the proximal femur".Patient was revised to a restoration modular stem construct, v40 28 -2.7 ceramic head, mdm/adm liner construct, and a competitor cable placed "to help prophylax against periprosthetic fracture" (no bone fractures are noted in the operative report).Rep provided the orthopedic consultation visit, revision operative report, pre- and post-revision x-rays and explant pictures.

• Brand Name: V40 COCR LFIT HEAD 44MM/+0
• 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: 8477782
• Report Number: 0002249697-2019-01508
• Device Sequence Number: 19248499
• Product Code: JDI
• UDI-Device Identifier: 07613327032734
• UDI-Public: 07613327032734
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• 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: 09/30/2012
• Device Catalogue Number: 6260-9-144
• Device Lot Number: TL1MMD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 04/03/2019
• 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
• Patient Age: 80 YR