MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR MODULAR RADIAL HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	11-210031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp-0940053 multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): - 11-210062 (66192759) - 11-210099 (341750) the customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that following an initial left radial head arthroplasty, the patient alleged that they were experiencing pain, swelling, nausea, weakness, and a possible allergic reaction approximately five (5) months post-implantation.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; b7; d2; g1; g3; g6; h1; h2; h10.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 is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; b6; d2; d4; g1; g3; g6; h1; h2; h3; h6.D4: expiration date corrected.H6: proposed annex g code mechanical (g04) head.Medical records confirm the reported event of pain and swelling.However, the reported event of an allergic reaction is not confirmed as the implants do include the compounds that the patient is allergic to (ferric fluoride and manganese fluoride).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a healthcare professional.Radiographs were not provided.A definitive root cause cannot be determined.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: EXPLOR MODULAR RADIAL HEAD
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19547449
• Report Number: 0001825034-2024-01615
• Device Sequence Number: 20036759
• Product Code: KWI
• UDI-Device Identifier: 00880304210370
• UDI-Public: (01)00880304210370(17)321207(10)65737274
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K051385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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: Lay User/Patient
• Device Catalogue Number: 11-210031
• Device Lot Number: 65737274
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 07/14/2024; 10/17/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/08/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 76 KG