MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0435
Medical Device Problem Codes	Material Erosion (1214); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening & wear involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event for wear was confirmed via medical 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 lfit 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 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 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 lfit 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 reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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 lfit 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.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19967720
• Report Number: 0002249697-2024-01118
• Device Sequence Number: 8801559
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• 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
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: 03/31/2013
• Device Catalogue Number: 6020-0435
• Device Lot Number: 26000505
• 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: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2008
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG