MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER -3.5 MM NECK LENGTH; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 802203601 item name femoral head 12/14 taper 36 mm diameter -3.5 mm neck length lot / # 65847676.G2: foreign: canada.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 there was residue present on the plastic container containing the implant.The surgery was completed using a new implant.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photo found white residue on the retainer lid that is visually consistent with glue transferred from the tyvek lid during the sealing operation due to a small clearance between the tyvek lid and the retainer.The adhesive residue is considered acceptable; therefore, this is not considered a reportable event as the sterility was not breached or compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided the condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to the packaging design due to the small clearance between the tyvek lid and retainer.This complaint was confirmed by evaluation of the provided photo 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 information.The following sections were updated: b4;d9;g3;h2;h3;h6.Product was returned and evaluated.Visual evaluation of the returned product confirmed white residue on the retainer lid that was visually consistent with glue transferred from the tyvek lid during the sealing operation due to a small clearance between the tyvek lid and the retainer.The adhesive residue was considered acceptable.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to the packaging design due to the small clearance between the tyvek lid and retainer.This complaint was confirmed by evaluation of the provided photo and returned product.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 event information is available at the time of this report.

• Brand Name: COCR FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER -3.5 MM NECK LENGTH
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19750720
• Report Number: 0002648920-2024-00231
• Device Sequence Number: 21118304
• Product Code: LPH
• UDI-Device Identifier: 00889024498877
• UDI-Public: (01)00889024498877(17)331113(10)66323643
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183457
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 802203601
• Device Lot Number: 66323643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 07/02/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 11/25/2024; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Patient Sex: Unknown