MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ML TAPER SZ17.5 STD OFFSET; PROSTHESIS, HIP

Catalog Number	00771101700
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual review of the returned packaged stem confirms carton item and lot label identification.Carton was returned with the outer shrink film and top flap previously opened.Bottom flap shows abrasion through the clear film and areas of carton are worn down.Double cavity was removed from the carton for evaluation and confirmed the outer cavity was broken with the tyvek seal previously peeled open.Inner cavity was sealed and undamaged.No other damage was noted.Sterility has been compromised.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event can be attributed to transit damage.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 trends.
Event or Problem Description
It was reported that the femoral stems packaging was cracked, and the top peeled back inside sealed box.No harm or impact reported.Due diligence is complete as multiple attempts were made; however, no further information is available.

• Brand Name: ML TAPER SZ17.5 STD OFFSET
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24499360
• Report Number: 0001822565-2026-00700
• Device Sequence Number: 10533643
• Product Code: JDI
• UDI-Device Identifier: 00889024131965
• UDI-Public: (01)00889024131965(17)280430(10)63886589
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00771101700
• Device Lot Number: 63886589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• 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: 02/16/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2018
• 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
• Patient Sex: Unknown