MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 ACTIVE ARTICULATION BEARING; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 163638 ¿ cocr head ¿ 560980, rd118852 ¿ m2a cup ¿ 765920, 11-104111 ¿ mallory femoral stem ¿ 334210.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a revision procedure approximately 1 year post implantation due to fracture of the poly component.The cup, head and poly components were removed and replaced.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: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting the placement of a dual mobility bearing and head during the patients first revision.The patient underwent a second revision due to fracture of the poly component.Ct scan confirmed failure of poly with no suspect of infection.It remains pretty much in one piece but had a very large cleft through it.It appeared like it probably got hung up on the edge of the metallic shell and got worn through to fatigue.Dhr was reviewed and no discrepancies were found.A root cause is unable to be determined, all though off-label use may have contributed to the reported event.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 additional event information to report at this time.

• Brand Name: E1 ACTIVE ARTICULATION BEARING
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9806751
• Report Number: 0001825034-2020-01050
• Device Sequence Number: 3003182
• Product Code: LPH
• UDI-Device Identifier: 00880304485020
• UDI-Public: (01)00880304485020
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K101336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: 05/11/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-200144
• Device Lot Number: 137800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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