MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (CR) LEFT 11MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Material Deformation (2976); Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: new zealand.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: unk persona tibia lot# unk.Mdr: 0001822565-2023-02451.Additional associated products: unk persona femoral- left lot# unk.Unk patella lot# unk.

Event Description

It was reported that the patient was revised due to aseptic loosening of the tibial component.The articular surface was removed and did show wear.Surgeon commented that the locking mechanism on the poly insert appeared deformed and upon investigation he found soft tissue trapped in the poly locking mechanism.Femoral component appeared well cemented but surgeon decided it should be removed, no specific cause was provided.Original patella button left insitu.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided photos identified a crack in the articular surface.Review of the device history record identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and reviewed by a health care professional.Review of the available records identified: the tibial implant appears loose and with abnormal angulation and knee varus malalignment.Radiolucency is noted along the tibial stem and there appears to be medial tibial implant subsidence.A joint effusion is noted.The complaint is confirmed via provided photos and medical records.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: (b)(4).The remainder of the mdr and investigation remain unchaged- udi correction only.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: ARTICULAR SURFACE FIXED BEARING (CR) LEFT 11MM
• 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: 17700546
• MDR Text Key: 322864421
• Report Number: 3007963827-2023-00239
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024235052
• UDI-Public: (01)00889024235052(17)230531(10)64046524
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 01/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42512000411
• Device Lot Number: 64046524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 01/02/2024
• Supplement Dates FDA Received: 12/07/2023; 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose