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

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: delta cer fem hd 28/0mm t1, cat#: 650-1158, lot#: 2018092315.Tprlc xr mp fp t1 pps 5x95mm, cat#: 51-149050, lot#: 6314874.Act artic e1 hip brg 28x38mm, cat#: ep-200144, lot#: 315330.G7 dual mobility liner 38mm c, cat#: 110024461, lot#: 385370.Foreign: country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location is unknown.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 - 2020 - 03505, 0001825034 - 2020 - 03507, 0001825034 - 2020 - 03508.

Event Description

It was reported the patient underwent a hip revision approximately one year post implantation due to pain.No additional information.

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.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.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 ACETABULAR SHL 48C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10553724
• MDR Text Key: 207542323
• Report Number: 0001825034-2020-03506
• 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: 11/06/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000661
• Device Lot Number: 6263144
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention