MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 10 DEGREE ELEVATED RIM; 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	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).00620005022 ¿ shell ¿ 64503204.00625006525 ¿ bone screw ¿ 64661377.Report source (b)(6).Complaint sample was returned and evaluated against the reported event.Visual evaluation identified nicks and gouges all over the outer surface of the liner indicative of attempts to insert the liner into the shell.The material was no protruding and no other damages were noted.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.A summary of the investigation was requested and sent to the customer.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
It was reported that during a hip procedure, the liner was opened and found poly protruding at the bottom of the liner.The surgeon opened a new device to complete the surgery.There was approximately 30 min of surgery delay.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: LINER 10 DEGREE ELEVATED RIM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 12010271
• Report Number: 0002648920-2021-00159
• Device Sequence Number: 3304152
• Product Code: LPH
• UDI-Device Identifier: 00889024124721
• UDI-Public: (01)00889024124721(17)240530(10)64437639
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00631005032
• Device Lot Number: 64437639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Weight: 53