MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 01/11/2019

Event Type  Injury  

Event Description

It was reported that a total hip study patient underwent revision on an unknown date due to painful psoas impingement confirmed by ultrasound.No additional information.

Manufacturer Narrative

(b)(4).Report source: foreign: country: (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.

Event Description

It was reported that a total hip study patient underwent revision approximately 3 years post implantation due to painful psoas impingement confirmed by ultrasound.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

No further event information available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: 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: 13470606
• MDR Text Key: 285155645
• Report Number: 0001825034-2022-00264
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524231
• UDI-Public: (01)00880304524231(17)251012(10)3659134
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 3659134
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/17/2022; 03/31/2022
• Supplement Dates FDA Received: 02/23/2022; 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: HEAD REF: 163668. LOT: 00J3698303.; LINER: REF: 10000850 LOT: 3697412.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female