MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THIN 37X8.6 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Extraskeletal ossification (1428); Cyst(s) (1800); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Synovitis (2094)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: therapy date: unknown, 181932 - vngd pat-spec cr fmrl - 632810, ep-189101 - e1 vngd as tib brg - 834110, 141215 - biomet ilok pri tib tray - 252660, 141318 - biomet finned pri stm - 815100.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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: 0001825034-2020-00969.0001825034-2020-00970.0001825034-2020-00971.0001825034-2020-00972.
Event or Problem Description
It was reported that the patient underwent a left knee procedure.Subsequently, the patient immediately developed a severe infection at the surgical site that resulted in amputation of the leg.Attempts have been made and no further information has been provided.
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.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.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient started wound vac.Approximately 7 months later, the patient had 95% wound closure.3 months later, the patient was unable to increase rom due to possible scar tissue and notes swelling.Approximately a month later, the ultrasound found subcutaneous fluid collection w/sinus tract to skin surface, suggests abscess, possibly from chronic osteomyelitis of distal femur.X-ray, indications for review, medial knee pain, swelling, bruising, open wound in medial aspect; no loosening, diffuse soft tissue swelling, joint effusion.A 3 phase bone scan-extensive ho from healing previous fracture of tibia.The patient presented left knee pain and review of x-rays suggest femoral loosening due to infection.No medical records were provided to confirm amputation.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.
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.The reported event of deep infection <90 days occurred post implantation.Zimmer biomet considers this event not reportable due to the following rationale.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.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.

• Brand Name: SERIES A PAT THIN 37X8.6 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9777510
• Report Number: 0001825034-2020-00973
• Device Sequence Number: 11365509
• Product Code: JWH
• UDI-Device Identifier: 00880304436701
• UDI-Public: (01)00880304436701
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/28/2020

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: 03/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 184788
• Device Lot Number: 570600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 06/08/2020; 12/22/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 05/26/2020; 06/09/2020; 12/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Weight: 102