MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE G RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#:42558000602; partial femur cemented size 6 right medial lot#:63760789.Item#:42528200708; partial articular surface right medial size g 8 mm lot#:63784873.Item#:unknown; palacos with gentamycin lot#:unknown.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: 3007963827-2020-00171.
Event or Problem Description
It was reported that a clinical study patient underwent a right knee tka approximately two years ago.Subsequently the patient had a revision after experiencing pain and inflammation due to a metal allergy.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.Device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE G RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10233163
• Report Number: 0001822565-2020-02388
• Device Sequence Number: 19606093
• Product Code: HSX
• UDI-Device Identifier: 00880304812734
• UDI-Public: (01)00880304812734
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000702
• Device Lot Number: 63720352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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 Weight: 81