MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 36 MM I.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00-8753-05601 63494016 shell with cluster holes porous 56 mm o.D.Size kk for use with kk liners; 00771100710 64189580 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 standard offset reduced neck length.Report source: foreign country: (b)(6).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 patient¿s hip was revised approximately one week post implantation due to disassociation of the liner from the cup.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/corrected updated: h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product/provided pictures identified nicks and gouges to the locking feature around the liner, scallops, and part face.A screw hole was noted through the liner.Potentially from the explant technique used.No other damage was noted.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 report 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 36 MM I.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9503420
• Report Number: 0001822565-2019-05370
• Device Sequence Number: 1541778
• Product Code: LPH
• UDI-Device Identifier: 00889024149786
• UDI-Public: (01)00889024149786
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 05/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 00875201236
• Device Lot Number: 63663603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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: PROSTHESIS, HIP; PROSTHESIS, HIP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR