MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHESIS, HIP

Model Number N/A

Device Problem Flaked (1246)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown head lot #: unknown, item #: unknown liner lot #: unknown, item #: unknown stem lot #: unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the surgeon implanted a 52 g7 cup but noticed some of the porous coating seem to rub off the cup and he could see metal debris in the wound.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by visual examination of the device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is most likely attributed to a manufacturing deficiency.Visual examination of the shell did not identify that the coating is flaking more than expected.There is an area on the shell with reduced porous coating coverage.The likely condition of the product when it left zimmer biomet is non-conforming to specification.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 52E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9607403
• MDR Text Key: 176078687
• Report Number: 0001825034-2020-00276
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: 00880304524224
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• 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: 010000663
• Device Lot Number: 6587127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 159