MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM 28MM RNGLOC LNR 10DEG25; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was found that the universal shell cannot lock with the liner during the surgery.No additional information.
Additional Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2022-00258.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was found that the universal shell cannot lock with the liner during the surgery.The liner was used during surgery.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, h2, h3, h6 complaint sample was evaluated and the reported event was confirmed.One univ 2-hole shl 60mm lnr sz 25 was returned and evaluated.Upon visual inspection the device has no visible damage to the inside radius of the device or to the locking ring.Device history record (dhr) 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: ARCOM 28MM RNGLOC LNR 10DEG25
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13470918
• Report Number: 0001825034-2022-00276
• Device Sequence Number: 1790488
• Product Code: LPH
• UDI-Device Identifier: 00880304202498
• UDI-Public: (01)00880304202498(17)240523(10)433550
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K926107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/31/2022
• 2 Devices were Involved in the Event: 1 2

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: 05/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 11-105915
• Device Lot Number: 139160
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 03/28/2022; 03/28/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 02/10/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT#14-103660 LOT#277260 UNIV 2-HOLE SHL
• Patient Sex: Female
• Patient Weight: 58 KG