MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: 192011, echo por fmrl nc 11x135mm, 868030, 650-1162, delta cer fem hd 32/0mm t1, 2015111797, 110003619, biolox delta cer lnr 32mm f, 3409715.Report source, foreign - the event occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01483.

Event Description

It was reported that three months after a total hip arthroplasty procedure the patient experienced pain, discomfort, difficulty walking, washing, and performing usual activities.It was also reported that there were some limitations in ordinary activity or work and sometimes required pain medicine stronger than aspirin.It was reported that the patient had to limp and pain interfered with work and scaled a 5 out of 10 for the pain.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.192011, echo por fmrl nc 11x135mm, 868030.650-1162, delta cer fem hd 32/0mm t1, 2015111797.110003619, biolox delta cer lnr 32mm f, 3409715.103534, ti low profile screw 6.5x35mm, 3309998.103533, ti low profile screw 6.5x30mm, 3303065.103531, ti low profile screw 6.5x20mm, 3408200.103531, ti low profile screw 6.5x20mm, 3408199.

Event Description

It was reported that three months after a total hip arthroplasty procedure the patient experienced pain, discomfort, difficulty walking, washing, and performing usual activities.It was also reported that there were some limitations in ordinary activity or work and sometimes required pain medicine stronger than aspirin.It was reported that the patient had to limp and pain interfered with work and scaled a 5 out of 10 for the pain.Patient has a difference in leg length of 2-3 cm.The patient experienced a complication due to bursitis trochanterica.A 2 cm insert in the right footwear was used as a permanent aid.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7296778
• MDR Text Key: 100953564
• Report Number: 0001825034-2018-01484
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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: 3813901
• Other Device ID Number: (01) 00880304524231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 78