MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM -5 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-036
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "head and stem are loose." an accolade stem and lift head were revised to a biolox head and restoration modular stem construct.Update per medical review: the preoperative x-ray did show eccentricity of the head neck junction but did not show frank loosening of the stem.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a metal head was reported.The event was confirmed via medial 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 records by a clinical consultant indicated: "no medical data, patient records pre or postoperative history were provided for review.This report is based on the pi report and 1 preop image and two close-up postop images.It would appear that the patient had a lift cobalt chrome head combined with a tmzf stem.The x-ray shows eccentricity of the head-neck junction likely the result of trunnionosis and wear.The stem and head went on to revision.Event confirmation: a revision arthroplasty can be confirmed only by the pi report.The x-rays of the revision are unlabeled and undated so cannot be necessarily attributed to the same patient.The preoperative x-ray did show eccentricity of the head neck junction but did not show frank loosening of the stem.Root cause: a root cause cannot be attributed as the event cannot be confirmed.That said, the preoperative x-rays showed marked trunnion wear and eccentricity of the head that would have been the reason for a revision if confirmed.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on jan with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to loosening.A review of the provided medical records by a clinical consultant indicated: "no medical data, patient records pre or postoperative history were provided for review.This report is based on the pi report and 1 preop image and two close-up postop images.It would appear that the patient had a lift cobalt chrome head combined with a tmzf stem.The x-ray shows eccentricity of the head-neck junction likely the result of trunnionosis and wear.The stem and head went on to revision.Event confirmation: a revision arthroplasty can be confirmed only by the pi report.The x-rays of the revision are unlabeled and undated so cannot be necessarily attributed to the same patient.The preoperative x-ray did show eccentricity of the head neck junction but did not show frank loosening of the stem.Root cause: a root cause cannot be attributed as the event cannot be confirmed.That said, the preoperative x-rays showed marked trunnion wear and eccentricity of the head that would have been the reason for a revision if confirmed.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa was initiated for the lift v40 cocr heads within scope of 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.

• Brand Name: V40 COCR LFIT HEAD 36MM -5 OFFSET
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19971869
• Report Number: 0002249697-2024-01119
• Device Sequence Number: 7075615
• Product Code: JDI
• UDI-Device Identifier: 07613327032291
• UDI-Public: 07613327032291
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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: 01/31/2013
• Device Catalogue Number: 6260-9-036
• Device Lot Number: D0XMAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG