MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT W/WR THN 28 1 PEG; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure three years post implantation due to painful patella and femoral loosening.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: vngd ssk 360 femur r 67.5 t 67.5mm catalog # 185265 lot # 6840257.Vngd ssk ps tib brg 16x63/67 x 16 catalog #: 185066 lot #: 767190.Vg 360 univ pst fm aug 67.5x5 7.5x5mm catalog #: 185345 lot #: 196360.Biomet tibial locking bar catalog #: 141205 lot #: 304250.Integral revision 14x225mm rt catalog #: 166044 lot #: a113.Vg 360 dst fm ag 67.5x5 rl/lm mm rl/lm catalog #: 185305 lot #: 101710.Bmt splined knee stm v2 14x120 120 catalog #: 148317 lot #: 139980.Zimmer round gigli saw blade catalog #: 2808-02 lot #: 64982256.Zimmer round gigli saw blade catalog #: 2808-02 lot #: 64982256.Report source: (b)(6).Customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2021-03459.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4 - it is unknown which 1 of the 2 reported devices was revised due to painful patella and femoral loosening.It is unknown which exact device encountered this issue, it is one of the following: item name: series a pat w/wr thn 28 1 peg item#: 184722, lot#: 410380, manufacture date: sep 3, 2014, sterile expiry date: aug 31, 2019, udi: n/a, 510k: k040770, pro code: jwh.Or item name: series a pat thn 28 3 peg, item#:184782, lot#: 187960 , manufacture date: jul 2, 2018, sterile expiry date: jul 2, 2023, udi: (b)(4).510k: k040770, pro code: jwh.D10 - medical products: vngd ssk 360 femur r 67.5 catalog # 185265 lot # 6030464.Series a pat thn 28 3 peg catalog # 184782 lot # 187960, bmt gb knee stm 12x40 catalog # 148142 lot # 485110, bmt gb knee stm 14x40 catalog # 148144 lot # 915370.Vngd ssk psc tib brg 12x63/67 catalog # 183862 lot # 427280, bmt 360 tib tray 67mm catalog # 185202 lot # 723760, bmt 360 tib sm cruciate wing catalog # 185650 lot # 712250, thin osteotome blade 8mm catalog # 430052 lot # 471937, 1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 813530, 1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 813530.Multiple mdr reports were filled for this event: 0001825034-2022-01320.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The additional information received doesn't change the previous investigation.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.

• Brand Name: SERIES A PAT W/WR THN 28 1 PEG
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13235368
• Report Number: 0001825034-2021-03460
• Device Sequence Number: 17281925
• Product Code: JWH
• UDI-Device Identifier: 00880304436633
• UDI-Public: (01)00880304436633(17)240710(10)826490
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2022

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 184722
• Device Lot Number: 410380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 04/25/2022; 05/10/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/29/2022; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female