MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on the postoperative x-ray of an initial total hip replacement, it was found that the screw was outside of the cup, and the cup did not seem to be fully attached to the acetabular.Followed proper technique, used trilogy screw, with g7 specific golden drill guide and drill shaft.Same day re-opened and revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 010000856 g7 neutral e1 liner 36mm d 6984458; 00877503601 bioloxâ ceramic head 3081675; 00771100600 femoral stem 12/14 65059818; 00625006530 bone scr 6.5x30 self-tap j6925767; 00625006525 bone scr 6.5x25 self-tap j7021980; 00625006525 bone scr 6.5x25 self-tap j7021980.Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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: 0001822565-2022-00947.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.One g7 pps ltd acet shell 50d item# 010000662 lot# 7085818 was returned and evaluated.Upon visual inspection the returned d shell has scuffing and nicks to the inner radius.The center hole has a nick on the thread.Two of the three side holes had damage to the threads with no thread analysis done due to damage.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: left total hip arthroplasty with loosening of the acetabular cup with one of the screws completely within the bone and not seen involving the acetabular cup.Device history record 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• 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: 13977386
• Report Number: 0001825034-2022-00684
• Device Sequence Number: 5568159
• Product Code: PBI
• UDI-Device Identifier: 00880304524217
• UDI-Public: (01)00880304524217(17)310823(10)7085818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K121874
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 010000662
• Device Lot Number: 7085818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown