MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RNGLC LOCKING RING SZ 25; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent 4 previous left hip revisions within 14 years post implantation.Subsequently, that patient underwent a fifth revision approximately 4 months later due to unknown reasons.The head, liner and locking ring were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown cup ¿ unknown part and lot.Unknown stem ¿ unknown part and lot.11-107424 ¿ freedom liner ¿ 758220.11-107017 ¿ freedom head ¿ 039250.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00303, 0001825034 - 2023 - 00304.
Additional Manufacturer Narrative
Upon reassessment of the additional information, it was found that this device did not contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the additional information, it was found that this device did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: RNGLC LOCKING RING SZ 25
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16395253
• Report Number: 0001825034-2023-00302
• Device Sequence Number: 6375284
• Product Code: LPH
• UDI-Device Identifier: 00880304191662
• UDI-Public: (01)00880304191662(17)251207(10)332590
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K030055
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 105425
• Device Lot Number: 332590
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Female