MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PALACOS R 1X40 SINGLE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994); Swelling (2091); Osteolysis (2377); No Information (3190)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: 0001822565 - 2019 - 05100, 0001822565 - 2019 - 05101, 0001822565 - 2019 - 05102.

Event Description

It was reported patient underwent an unknown revision after an unknown amount of time post implantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were reviewed and identified the patient reported feeling a sudden change in their knee with pain and swelling.Office x-rays revealed osteolysis and erosions under the tibial plateau medially.During the revision fracture was noticed across the medial tibial plateau and erosion was noted medially.The femur was noted to be intact.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.D11: associated products : item#:00111214001;palacos r 1x40 single lot#:7714364 item#:00598005701;stemmed tibial component precoat size 7 lot#:62369770 item#:00599601751;femoral component option for cemented use only size g left lot#:62438666 item#:00598009000;stem extension replacement screw lot#:62454245 item#:00596009900;taper stem plug lot#:62448307 item#:00596405010;articular surface size gh 10 mm height "use with plate 7 lot#: 62463371 the following sections were updated: a1; a2; a3; b1; b2; b3; b4; b5; b7; d1; d2; d4; d6; d7; d11; g4; g5; g7; h1; h2; h6 multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-05100 0002648920-2020-00133.

Event Description

The patient was revised approximately four years, three months after his initial left tka due to pain and swelling.Radiology reviews revealed osteolysis and erosions under the medial tibial plateau which the surgeon attributed to early loosening of the tibial stem.During the revision, a fracture was noted on the medial tibial plateau and erosions confirmed.The tibial components were revised without complication, the patella was resurfaced, and the femoral components were left intact.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d4 (lot); g4; g7; h1; h2.

Event Description

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

• Brand Name: PALACOS R 1X40 SINGLE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9435159
• MDR Text Key: 169797319
• Report Number: 0001822565-2019-05099
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K030902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2020

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 Model Number: N/A
• Device Catalogue Number: 00111214001
• Device Lot Number: 77104364
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/08/2019
• Supplement Dates Manufacturer Received: 02/14/2020; 05/14/2020; 06/09/2020
• Supplement Dates FDA Received: 02/26/2020; 05/14/2020; 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK CUP; UNK HEAD; UNK LINER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR