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 Codes	Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Lot specific voluntary recall ra 2016-028 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
It was reported through the submission of a revision implant sheet that patient's hip was revised.Revision implants were a restoration modular stem construct, biolox delta 28 +0 head, an adm/mdm liner construct, and a dose of hydroset cement.Update: head disassociation, trunnion wear & metallosis.
Additional Manufacturer Narrative
An event regarding disassociation and wear/ metallosis involving a metal head which was mated with an accolade stem was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: the event, a revision surgery, was confirmed via an op note.The revision was for head-stem disassociation, trunnion wear and metallosis as noted during the surgery.Root cause: the root cause of the dissociation and metallosis was likely an lfit head-trunnion problem.The lot numbers would need to be checked to confirm.-product history review: product history review could not be performed due to insufficient information.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's hip was revised due to head-stem disassociation, trunnion wear and metallosis which was confirmed via clinician review.The subject device has been identified to be within scope of an nc and capa.A lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of said nc and 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.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's hip was revised.Revision implants were a restoration modular stem construct, biolox delta 28 +0 head, an adm/mdm liner construct, and a dose of hydroset cement.Update: head disassociation, trunnion wear & metallosis.

• 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: 12317362
• Report Number: 0002249697-2021-01379
• Device Sequence Number: 2826438
• Product Code: JDI
• UDI-Device Identifier: 07613327032734
• UDI-Public: 07613327032734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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 Model Number: 6260-9-144
• Device Catalogue Number: 6260-9-144
• Device Lot Number: MHD64A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: 2249697-05-07-2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR