MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION REPLACEMENT SCREW; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Swelling (2091); Osteolysis (2377)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi# (b)(4).Concomitant medical products: item#:00111214001;palacos r 1x40 single lot#:7714364, 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#:00596009900;taper stem plug lot#:62448307, item#:00596405010;articular surface size gh 10 mm height "use with plate 7 lot#: 62463371.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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 filed for this event, please see associated reports: 0001822565-2019-05100, 0001822565-2019-05099, 0002648920-2020-00133.
Event or Problem 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.
Event or Problem Description
No additional information reported.
Additional Manufacturer Narrative
Upon evaluation, this device is not related to the event and this report will be considered void; the event is being reported on 0001822565-2019-05100, 0001822565-2019-05099, 0002648920-2020-00133.

• Brand Name: STEM EXTENSION REPLACEMENT SCREW
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9792843
• Report Number: 0001822565-2020-00812
• Device Sequence Number: 11345601
• Product Code: JWH
• UDI-Device Identifier: 00889024217669
• UDI-Public: (01)00889024217669
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00598009000
• Device Lot Number: 62454245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR