MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL SIZE EF 10 MM HEIGHT USE WITH PLATE 5,6; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during total knee arthroplasty the surgeon was having difficulty getting the poly trial to seat properly therefore he used an impactor and the poly broke.

Manufacturer Narrative

Visual examination of the returned product identified damage related to repeated use for more than 4 years and confirmed that the instrument was fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Supplier dhr was not reviewed ref: (b)(4).Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history identified additional similar complaints for the reported item(s) and part and lot combination(s).Complaints are monitored through monthly complaint review (reference (b)(4) in order to identify potential adverse trends.Medical records were not provided.The root cause of the reported issue is due to surgeon impacting the articular surface with the impactor.Per package insert: (b)(4).On page03 states not subject instruments to high loads and/or impact as breakage can occur.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

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

• Brand Name: ARTICULAR SURFACE PROVISIONAL SIZE EF 10 MM HEIGHT USE WITH PLATE 5,6
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10478457
• MDR Text Key: 205178623
• Report Number: 0001822565-2020-03120
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596104010
• Device Lot Number: 63185332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1