MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. SIZE HH WITH CONSTRAINING RING CONSTRAINED LINER; PROSTHESIS, HIPS

Catalog Number	00875800928
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during surgery that the surgeon was having a problem implanting the liner into the shell.The liner did not fully seat properly while impacting and popped out while the surgeon tried to fit the liner into the shell.
Additional Manufacturer Narrative
(b)(4).D1: 28mm i.D.Size hh with constraining ring constrained liner use with 50mm o.D.Size hh shell do not use with skirted heads.G2: foreign: india.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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 and corrected information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6.The following section was corrected: b3.Product was returned and evaluated.Visual examination of the returned product identified that the liner showed deformations on the lip where the bottom of the ring seats.Liner anti rotation scallops had deformation damage and gouges.Scratches, gouges, and burrs were noted to the liner across outer, inner, and top surfaces from attempted use.Possible tool marks were present on the fingers and top surface of the liner from attempted use.Liner and ring product dimensions were measured and found to be within product specifications.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported ring as a component of the liner was reviewed for compatibility with no issues noted.Insufficient information provided for the shell; therefore, unable to perform a compatibility check with the shell.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review, the complaint was confirmed.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: 28MM I.D. SIZE HH WITH CONSTRAINING RING CONSTRAINED LINER
• Common Device Name: PROSTHESIS, HIPS
• 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: 21216371
• Report Number: 0001822565-2025-00162
• Device Sequence Number: 3326477
• Product Code: KWZ
• UDI-Device Identifier: 00889024151819
• UDI-Public: (01)00889024151819(17)291021(10)66433114
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/07/2025

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: Lay User/Patient
• Device Catalogue Number: 00875800928
• Device Lot Number: 66433114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 05/06/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/11/2025; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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
• Patient Sex: Unknown