MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00875304801, 64326552, shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners.00875200832, 64239284 ,liner elevated rim 32 mm i.D.Size gg for use with 48 mm o.D.Size gg shell.Unknown stem.Unknown head.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00001.
Event or Problem Description
It was reported that during hip surgery, the liner would not seat into the cup.After repeated attempts to seat the liner into the cup, it was found that the cup had become loose.The 48 mm cup was then removed and replaced with a 50mm cup.The liner was then implanted with no issues.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were : updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, h10.Visual examination of the returned products identified no issues with the devices.The liner fully seated within the shell when received.Nicks and gouges, consistent with implantation were noted on the liner and shell around the threaded hole.No other damage was noted.Dimensional analysis was not performed as the devices were returned assembled.Complaint sample was evaluated and the reported event was not confirmed.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: LINER ELEVATED RIM 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9537926
• Report Number: 0001822565-2020-00002
• Device Sequence Number: 19404035
• Product Code: LPH
• UDI-Device Identifier: 00889024149670
• UDI-Public: (01)00889024149670
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00875200832
• Device Lot Number: 64239284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.