MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY IT HIGHLY CROSSLINKED POLY 22MM I.D. SIZE DD ELEVATED RIM LINER; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00875704202 42mm o.D size dd porous uncemented with multi-holes shell use with dd liners 63692517.G2: foreign: india.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 00925.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 the liner did not fix in the cup and the incorrect shell implants were inside the box.While fixing the liner, the patient's acetabular wall broke.The surgery was delayed two hours.The surgeon abandoned the case, and the patient will need another surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;d9;g3;h2;h3;h6.The following section was corrected: d1.Product was returned and evaluated.A visual examination of the returned liner identified indentations, nicks, and gouges to the elevated rim side, anti-rotation scallops, elevated rim outer diameter, and spherical surface from attempted use.No other damage was noted to the liner.Visual review of the returned shell showed scratches, gouges, tool marks, and deformation from attempted use.Damage was noted to the rim face, anti-rotation scallop cutouts, taper wall, and inner spherical bottom.No other damage was noted.Complaint alleged the incorrect shell implants were inside the box.All four product identifiers were inspected to the print and the shell was found to be conforming to product identifiers listed.Overall height was also measured and met product specification.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined for the liner and shell not assembling.No problem was found in relation to the shell implant being the wrong size in the box, as the device was measured and conformed to the correct size specifications.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 additional information to report.

• Brand Name: LONGEVITY IT HIGHLY CROSSLINKED POLY 22MM I.D. SIZE DD ELEVATED RIM 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: 18907193
• Report Number: 0001822565-2024-00926
• Device Sequence Number: 15014770
• Product Code: LPH
• UDI-Device Identifier: 00889024149618
• UDI-Public: (01)00889024149618(17)280328(10)65930628
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101229
• 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
• Report Date (Section B): 07/15/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00875200522
• Device Lot Number: 65930628
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female