MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STD RT SIZE 7; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 03/04/2023

Event Type  Injury  

Event Description

It was reported that there was a revision for instability.Patient notes/records are not available.

Manufacturer Narrative

(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested, but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 42522100714, articular surface medial congruent (mc) right 14 mm, lot# 64832636, mdr: 3007963827-2023-00096.Additional associated products: 42532007102, tibia cemented 5 degree stemmed right size e, lot# 64803053; 42540200032, all-poly patella cemented 32 mm diameter, lot# 64816178; 42557000114, stem extension tapered cemented 14mm dia +30mm length, lot# 64815596.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical g4-femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records finds that the implant fit is maintained.There is varus alignment of the arthroplasty components.Bone quality appears osteopenic.There is no evidence of implant malfunction.Complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STD RT SIZE 7
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16853177
• MDR Text Key: 314373859
• Report Number: 3007963827-2023-00097
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024230361
• UDI-Public: (01)00889024230361(17)300920(10)64839234
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502606202
• Device Lot Number: 64839234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female