MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 83MM; PROSTHESIS KNEE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: 2005.Concomitant medical product: vngd cr tib brg 14x79/83, catalog # 183464 lot # unknown, maxim ilok ana pri fml 75 rt, catalog # 140014 lot # unknown.(b)(6).Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-01577, 0001825034-2018-01579.Product location is unknown.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.Subsequently, the patient was revised due to wear, osteolysis, loosening and fracture of implants.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.The following sections have been updated.Concomitant medical products: biomet finned stem, catalog #: 141314, lot #: 789370.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01324, 0001825304-2018-01577, 0001825034-2018-01579, 0001825034-2018-02607.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Medical products: biomet ilok pri tib tray 83mm p/n 141216 l/n 778570, max pri dcm tib brng14x79/83mm p/n 11-146174 l/n 491750, maxim ilok ana pri fml 75 rt p/n 140014 l/n 089770, biomet finned pri stem 40mm p/n 141314 l/n 789370.Complaint sample was evaluated and the reported event was confirmed.Visual inspection was performed on the returned implants.It was noted the tibial tray was fractured and has bone cement adhered to cementing surface.Scratches were noted on the polished condyles of the femoral component and have bone cement adhered on the cementing side.Extensive wear, gouging, and discoloration was seen on the tibial bearing.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01577-3, 0001825034-2018-01579-3, 0001825034-2018-02607-2.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Implant date - (b)(6) 2005.Medical products: unknown optipac bone cement plus catalog # unknown lot # unknown.

• Brand Name: BIOMET ILOK PRI TIB TRAY 83MM
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7303890
• MDR Text Key: 101200630
• Report Number: 0001825034-2018-01324
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK010212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2018

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: 03/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 141216
• Device Lot Number: 778570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/15/2018; 03/30/2018; 05/31/2018
• Supplement Dates FDA Received: 04/13/2018; 04/26/2018; 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109