MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 54-F PPS LIMITED ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Multiple mdr¿s were submitted for this event.Please see reports: 0001825034 - 2017 - 07704, 0001825034 - 2017 - 07705.Concomitant- 192013 echo por fmrl nc 13x145mm lot# 751010; 010000664 g7 pps ltd acet shell 54f lot# 3790818; 650-1161 delta cer fem hd 32/+3mm t1 lot# 2016021417; 110003619 biolox delta cer lnr 32mm f lot# 3230050.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported that the patient suffered fascia rupture.The patient subsequently underwent a procedure for suture of fascia.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed via clinical operative notes.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required.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 54-F PPS LIMITED 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: 6908723
• MDR Text Key: 88015373
• Report Number: 0001825034-2017-07705
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 3790818
• Other Device ID Number: (01) 00880304524231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 78