MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 60G; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 01604.Concomitant product(s): a 192114 echo por fmrl lat nc 14x150mm, lot 013570; 650-1160 delta cer fem hd 32/+6mm t1 lot 2015110412; 110003629 biolox delta cer lnr 32mm g lot 3409704.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

It was reported that three months after a total hip arthroplasty procedure was performed on the right hip the patient reported pain, discomfort, difficulty walking, and difficulty performing usual activities at the 3 month follow up.It was also reported that the patient found it difficult to do shopping and that the pain interfered with usual work at the 3 month follow-up.The patient reported at the 1 year follow up that there were no problems performing usual activities; however, severe pain - 'shooting', 'stabbing', or 'spasms' was reported for one or two days within the past four weeks.The satisfaction score at the 1-year followup visit was 9.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: G7 PPS LTD ACET SHELL 60G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7305850
• MDR Text Key: 101257403
• Report Number: 0001825034-2018-01605
• 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: 03/01/2018
• 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: 010000667
• Device Lot Number: 3575465
• Other Device ID Number: (01) 00880304524262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• 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: 74 YR
• Patient Weight: 74