MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS - HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item 51-106100 - lot 3430142 - tprlc 133 mp type1 pps so 10.0, item 110003623 - lot 3401343 - biolox delta cer lnr 36mm f, item 650-0661 - lot 2015051195 - delta ceramic fem hd 36/0mm.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00869.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Item # 010000665, lot #3425883; review of the device history record identified a deviation at porous coat where 3 pieces were reworked to finish coating.At ceramic bead blast, 2 of the reworked pieces were scrapped due to failing graticule testing.Concessions were also noted; however, this did not affect the reported event.This device is used for treatment.The reported components were reviewed for compatibility with no issues noted.A complaint history review determined that no further action is required as no trends were identified.No medical records received.Root cause could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.This report is being submitted late as it has been identified in remediation.

Event Description

Clinical study (b)(6) reported patient underwent total hip arthroplasty (tha) for right hip on (b)(6) 2015.One year post op it was reported that patient was having mild pain, moderate limp, needs 2 crutches or walker however, according to oxford hip score patient was limping often.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• 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: 7262775
• MDR Text Key: 99773806
• Report Number: 0001825034-2018-00868
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• 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: 010000665
• Device Lot Number: 3425883
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 52