MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROSTHESIS, HIP

Catalog Number 010000661

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651); Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01006.0001822565-2024-01007.0001825034-2024-00819.D10: cat #: 30103203 / g7 vit e neutral lnr 32mm c / lot #: 66394401.Cat #: 00625006530 / bone scr 6.5x30 self-tap / lot #: j7607604.Cat #: 51-107090 / tprlc 133 mp type1 pps ho 9.0 / lot #: 7498707.Cat #: 650-1067 / cer option type 1 tpr sleve +3 / lot #: 3141011.Cat #: 650-1056 / cer bioloxd option hd 32mm / lot #: 3165601.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that a patient underwent a left hip procedure approximately nine days post implantation for unknown reasons.All of the items were removed and replaced.Attempts have been made and no further information is available.

Event Description

It was reported, that a patient underwent a left hip procedure.Approximately, nine days post implantation for pain and instability.All of the items were removed and replaced.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted, to relay additional information.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 48C
• Type of Device: 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: 18977318
• MDR Text Key: 338559392
• Report Number: 0001825034-2024-00818
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524200
• UDI-Public: (01)00880304524200(17)330731(10)J7362795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 010000661
• Device Lot Number: J7362795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization