MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE JJ NEUTRAL LINER USE WITH 54MM O.D. SIZE JJ SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the circulating nurse opened the implant, and the scrub nurse noticed a hair inside of the sterile packaging laying on the inside of the liner.There was no consequences or impact to the patient.
Additional Manufacturer Narrative
(b)(4).Report source: 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photos found a hair like debris on the device.The packaging was previously opened and therefore, the source of the debris cannot be confirmed.This complaint cannot be confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was previously opened.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 at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product found a hair like debris on the device.The packaging was previously opened and therefore, the source of the debris cannot be confirmed.This complaint cannot be confirmed.Return of the product does not alter the previous investigation.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 at the time of this report.

• Brand Name: 36MM I.D. SIZE JJ NEUTRAL LINER USE WITH 54MM O.D. SIZE JJ SHELL
• 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: 16453904
• Report Number: 0001822565-2023-00530
• Device Sequence Number: 5859948
• Product Code: LPH
• UDI-Device Identifier: 00889024149168
• UDI-Public: (01)00889024149168(17)260629(10)64999332
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151448
• 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,Followup
• Report Date (Section B): 04/27/2023

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 Expiration Date: 06/29/2026
• Device Model Number: N/A
• Device Catalogue Number: 00875101136
• Device Lot Number: 64999332
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 04/26/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/15/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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