MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 58G; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01438.Concomitant product(s): a 192112 echo por fmrl lat nc 12x140mm lot 876340; 650-1162 delta cer fem hd 32/0mm t1 lot 2016031399; 110003629 biolox delta cer lnr 32mm g lot 3409702.Report source: foreign.The event occurred in (b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Device remains implanted.

Event Description

Clinical study 518 reported that patient underwent right total hip replacement.At the 3-month post-op visit the patient experienced - problems washing, dressing/performing usual activities, moderate pain.Harris - moderate, tolerable makes concessions to pain, some limitation of ordinary activity or work.May require occasional pain medicine stronger than aspirin.Moderate limp, uses a cane most of the time.(b)(6) - severe pain, moderate trouble washing/drying, moderate trouble getting in or out of car, extremely difficult to put on socks, impossible to shop, extremely difficult to climb stairs, often limping, moderately painful to stand up, limping all of the time, pain has greatly interfered with work.Pain in bed most nights.Pain scale: five when moving and at rest.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

It has been determined that this event is not reportable and the initial medwatch was submitted in error.Please void this entry.

• Brand Name: G7 PPS LTD ACET SHELL 58G
• 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: 7295881
• MDR Text Key: 100913801
• Report Number: 0001825034-2018-01439
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000666
• Device Lot Number: 3789267
• Other Device ID Number: (01) 00880304524255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 02/03/2017
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2016
• 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): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 134