MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE E HIGH WALL LINER; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 there was hair stuck on the implant.The circulator opened the implant and had it available for the scrub nurse to take.The scrub nurse noticed the hair on the cup of the liner.The scrub nurse refused to take the implant.The packaging was intact before opening.There was no consequences or impact to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.No product was returned; visual and dimensional evaluations could not be performed.Visual evaluation of the provided photos found a hair-like fiber on the device.The packaging has been previously opened; therefore, the origin of the fiber cannot be determined.This complaint cannot be confirmed as the product was previously opened.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d9; g3; h2; h6.Visual evaluation of the returned product found a hair-like debris.The sterile packaging was previously opened.This complaint has been confirmed by evaluation of the returned product.Return of the product does not alter the previous investigation.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned 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.

• Brand Name: 36MM I.D. SIZE E HIGH WALL LINER
• Common Device Name: PROTHESIS, 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: 16691276
• Report Number: 0001822565-2023-00946
• Device Sequence Number: 5921538
• Product Code: LPH
• UDI-Device Identifier: 00889024520486
• UDI-Public: (01)00889024520486(17)271009(10)65604132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2023

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 Model Number: N/A
• Device Catalogue Number: 30123605
• Device Lot Number: 65604132
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 10/02/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/03/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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