MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE 32MM I.D. SIZE II ELEVATED RIM LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ canada.The 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
It was reported that during surgery, the liner could not be placed in the cup.A new liner was used to complete the procedure.There was no known impact or consequences to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product/provided pictures identified gouges and indentations to the rim, inner spherical surface, and elevated anti rotation scallops.Cut outs on the outer spherical surface show indentations and deformation from attempted implanting.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be 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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE 32MM I.D. SIZE II ELEVATED RIM LINER
• 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: 19165833
• Report Number: 0001822565-2024-01375
• Device Sequence Number: 7324364
• Product Code: JDI
• UDI-Device Identifier: 00889024149717
• UDI-Public: (01)00889024149717(17)281010(10)66258085
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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 Model Number: N/A
• Device Catalogue Number: 00875201032
• Device Lot Number: 66258085
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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