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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 07/08/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: g7 neutral liner, # item 010000857, lot 2921390; cer bioloxd option head, # item 650-1057, lot 773770; cer option type 1 taper sleve, # item 650-1065, lot 683160; tprlc133 mp t1 pps so 6x97.5mm, # item 51-108060, lot 2479105.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06147, 0001825034-2018-06149, 0001825034-2018-06153 and 0001825034-2018-06154.Reported event was confirmed by review of operative notes provided.Revision op note shows estimated blood loss 1700ml.The patient was revised due to increased pain, leg length inequality, chronic periprosthetic fracture with a grossly loose stem.Cerclage cables placed to reduce the lesser trochanteric chronic fracture.Cup and liner left intact.Femoral head/neck and stem replaced.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.

Event Description

It was reported that the estimated blood loss was 1700 ml during revision due to periprosthetic femoral fracture.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: G7 PPS LTD ACETABULAR SHELL
• 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: 7957667
• MDR Text Key: 123434357
• Report Number: 0001825034-2018-09663
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 2804310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• 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 Age: 62 YR
• Patient Weight: 122