MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4; PROSTHESIS, SHOULDER

Model Number	00-8400-044-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr's were filed in association with this reporting: 0001822565 -2019 -05408, 0001822565 -2019 -05410, 0001822565 -2019 -05411, 0001822565 -2019 -05412.Concomitant medical products: 00840001507 ulnar component plasma sprayed size 5 lot 63127158, primary di# (b)(6), 00840009000 humeral screw kit lot 63969924 primary di# (b)(6), 00840009400 articulation kit size 4 lot 64129150, primary di# (b)(6), 32810503800 cement restrictor lot 63252559, primary di# (b)(6).Report source: foreign.Event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported the patient is being considered for a revision to address infection and related pain less than a year post implantation.No further information is available as the patient has not yet been revised.
Event or Problem Description
No further information is available as the patient has not yet been revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
The patient underwent a revision procedure due to pain and infection less than one year post implantation.No components were removed.The surgeon treated the patient with antibiotics.No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.B3: the event occurred on or after (b)(6) 2020.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9537487
• Report Number: 0001822565-2019-05409
• Device Sequence Number: 14060040
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: (01)00889024271340
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2020

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: 04/30/2026
• Device Model Number: 00-8400-044-10
• Device Catalogue Number: 00840004410
• Device Lot Number: 63319031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 05/12/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/03/2020; 05/18/2020
• 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; Other; Required Intervention