MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 31 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03935, 0001825034-2020-03936, 0001825034-2020-03937, 0001825034-2020-03963.Medical devices: vgxp xp e1 tib brg rm 11x63 catalog#: 195844 lot#: 641580, vgxp intlk femoral rt 62.5 catalog#: 195909 lot#: 758590, vgxp xp inlk pri tib tray 67mm catalog#: 195753 lot#: 206970, vgxp xp e1 tib brg rl 9x63 catalog#: 195772 lot#: 852680.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.
Event or Problem Description
It was reported that patient is experiencing pain approximately five years after implantation.No revision procedure has been reported.Attempts have been made and no further information has been provided.
Event or Problem Description
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.

• Brand Name: SERIES A PAT STD 31 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10763887
• Report Number: 0001825034-2020-03964
• Device Sequence Number: 16977692
• Product Code: JWH
• UDI-Device Identifier: 00880304431317
• UDI-Public: (01)00880304431317(17)200829(10)236110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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 Expiration Date: 08/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 184764
• Device Lot Number: 236110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: Other