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

Model Number	6260-9-144
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Ambulation or Postural Difficulties (2544); Reaction to Medicinal Component of Device (4574)
Date of Event	03/15/2020
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.
Event or Problem Description
The customer reported that an implant failed in a patient who had been implanted with a trident accolade combination.Accolade stem, femoral head and poly liner were all explanted.The trident cup that was in situ was perfect so wasn¿t explanted.This patient presented to the emergency department with rip hip pain.His x-rays shows signs of gross trunnion failure and femoral head ¿ neck dissociation.He underwent revision right hip surgery on (b)(6) 2020 when the affected explant was retrieved.The patient's metal ion levels were: serum cobalt (co) level of 274 nmol/l (normal, <10 nmol/l), serum chromium (cr) level of 94 nmol/l (normal, <15 nmol/l).
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and abnormal ion level involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 10 july 2020.This inspection indicated wear damage on the inner taper and distal surfaces of the head was consistent with interaction against the stem trunnion.The inner taper was examined further using a scanning electron microscope.A material analysis has been performed.The report concluded: damage on the returned and stem trunnion and head taper is consistent with the loss of taper lock.The eds and xrf analyzes showed that the components were consistent with their respective drawings.The debris on the stem was consistent with an oxide, corrosion product, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of the records provided confirmed the implant disassociation on the right side.Review of the implant stickers could define if this was a recalled head lot.Obtaining the implant may provide additional insight into the mechanism of disassociation.Intervention on the left hip may be considered before there is a dissociation of the head.Device history review: indicated 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 lot referenced.Conclusions: 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.
Event or Problem Description
The customer reported that an implant failed in a patient who had been implanted with a trident accolade combination.Accolade stem, femoral head and poly liner were all explanted.The trident cup that was in situ was perfect so wasn¿t explanted.This patient presented to the emergency department with rip hip pain.His x-rays shows signs of gross trunnion failure and femoral head ¿ neck dissociation.He underwent revision right hip surgery on (b)(6) 2020 when the affected explant was retrieved.The patient's metal ion levels were: serum cobalt (co) level of 274 nmol/l (normal, <10 nmol/l), serum chromium (cr) level of 94 nmol/l (normal, <15 nmol/l).

• 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: 10355356
• Report Number: 0002249697-2020-01586
• Device Sequence Number: 3623906
• Product Code: JDI
• UDI-Device Identifier: 07613327032734
• UDI-Public: 07613327032734
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 03/31/2014
• Device Model Number: 6260-9-144
• Device Catalogue Number: 6260-9-144
• Device Lot Number: MHD56L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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: 83 YR
• Patient Weight: 75