MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 58G; PROSTHESIS, HIPS

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).D.O.B: unknown month and day in (b)(6).Concomitant medical products: catalog#: 192114, echo por fmrl lat nc 14x150mm, lot#: 133930.Foreign report source: (b)(6).The device will not be returned for analysis as the device remains implanted; however, an investigation of the reported event is in progress.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: 0001825034-2021-00334.

Event Description

It was reported that approximately 2 years post implantation, the patient was experiencing an increase in pain with movement and frequent noise.Patient states noise is getting worse, and was prescribed physical therapy.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: catalog#: 192114 echo por fmrl lat nc 14x150mm lot#: 133930.Catalog#: 650-1162 delta cer fem hd 32/0mm t1 lot#: 2016120241.Catalog#: 110003629 biolox delta cer lnr 32mm g lot#: 3409704.The event was confirmed with medical records and radiographs received.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 58G
• Type of Device: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11274521
• MDR Text Key: 230119962
• Report Number: 0001825034-2021-00335
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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: 010000666
• Device Lot Number: 3726509
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 104