MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MM PEGS 46MM ST; PLATE, FIXATION, BONE

Catalog Number	110025446
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately four (4) months after a shoulder procedure, the plating system migrated from its intended position and the distal portion of the plate may have lifted.No revision surgery is planned at this time.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).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): - 110025444(926313) - 110025450(926294) - 110025450(926294) - 110025458(61271120) - 856135026(65686246) - 856135028(66204732) - 856135028(66421922) - 856135034(65686547) - 856135044(65686792) - 856135046(65686836).- g2: foreign - the event occurred in japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation (remains implanted in the patient).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
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were corrected: b1; b2; h1; h6; the following sections were updated: b4; b5; d2; d9; g1; g3; g6; h2; h3; h6; h10.The reported event is confirmed via medical review.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: lateral plate and screw fixation device of the right shoulder with possible partial withdrawal of the lateral plate distally in the interval.Overall fit and alignment of the implant is appropriate two months postop.There does appear to be partial withdrawal of the distal plate noted on the 3.5 month images which is new in the interval.A definitive root cause cannot be determined.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.

• Brand Name: 3.2MM PEGS 46MM ST
• Common Device Name: PLATE, FIXATION, BONE
• 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: 22330775
• Report Number: 0001825034-2025-01857
• Device Sequence Number: 12864488
• Product Code: HRS
• UDI-Device Identifier: 00887868530784
• UDI-Public: (01)00887868530784(17)340307(10)0926314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: Lay User/Patient
• Device Catalogue Number: 110025446
• Device Lot Number: 0926314
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male