MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.This event was previously reported on 0001822565-2020-03841.
Event or Problem Description
It was reported that the patient underwent a revision procedure post implantation for an unknown reason.The liner was replaced.No further event information available at the time of this report.

• Brand Name: LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL
• 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: 10984101
• Report Number: 0002648920-2020-00517
• Device Sequence Number: 2684952
• Product Code: LPH
• UDI-Device Identifier: 00889024124684
• UDI-Public: (01)00889024124684
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 00631004832
• Device Lot Number: 61204468
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/10/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention