MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR HD 22.2MM X +3; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a hip revision approximately 7 months post implantation due to dislocation.During the procedure, it was found that the metal head had popped out of the dual mobility head.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Implanted (b)(6) 2022.Concomitant medical products: p0560e46 ¿ avan e1 insert ¿ unknown lot.Report source united kingdom.The product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h4; h6.H6: component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: ZB 12/14 COCR HD 22.2MM X +3
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15529337
• Report Number: 0001822565-2022-02856
• Device Sequence Number: 19462853
• Product Code: LPH
• UDI-Device Identifier: 00889024498761
• UDI-Public: (01)00889024498761(17)310131(10)3058610
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2022

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 Model Number: N/A
• Device Catalogue Number: 802202203
• Device Lot Number: 3058610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 12/29/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 12/07/2022; 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown