MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-440
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	11/17/2020
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported 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.Not returned to the manufacturer.
Event or Problem Description
As reported: "revision [right] total hip done 11/17/20.Labs done for infection at time of surgery were negative.Implants can not be retrieved due to hospitals policy." revision due to dissociation of the head from the stem.Liner wear noted around it's rim.V40 head, 0° poly liner, and tmzf stem were revised to a 10° 36 mm eccentric liner and competitor femoral components.No further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "revision [right] total hip done (b)(6) 2020.Labs done for infection at time of surgery were negative.Implants can not be retrieved due to hospitals policy." revision due to dissociation of the head from the stem.Liner wear noted around it's rim.V40 head, 0° poly liner, and tmzf stem were revised to a 10° 36 mm eccentric liner and competitor femoral components.No further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation 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: product evaluation and results: no product was returned for evaluation however photographs were provided.The photographs show a recently explanted v40 cocr lfit head.Damage consistent with in vivo use and explantation damage is visible on the head.Medical records received and evaluation: confirmation: based on the x-ray and the pi report the event can be confirmed.Root cause: the root cause of the dissociation cannot be stated without additional information.Obtaining the explants may contribute to determining the root cause or evidence/source of material failure.Operative notes or clinical documents particularly intraoperative findings may also contribute.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: the event was confirmed through clinician review of the provided medical records.The root cause of the dissociation cannot be stated without additional information.Obtaining the implants may contribute to determining the root cause or evidence/source of material failure.Operative notes or clinical documents particularly intraoperative findings may also contribute.The subject device has been identified to be within scope of nc/capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of nc/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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.H3 other text : device not returned.

• Brand Name: V40 COCR LFIT HEAD 40MM/+12
• 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: 10982471
• Report Number: 0002249697-2020-02628
• Device Sequence Number: 703075
• Product Code: JDI
• UDI-Device Identifier: 07613327032772
• UDI-Public: 07613327032772
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 11/30/2011
• Device Model Number: 6260-9-440
• Device Catalogue Number: 6260-9-440
• Device Lot Number: 45YMRA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/19/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 91