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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: 010000858, g7 neutral e1 liner 36mm f, 6237888; 193011, echo b-mtrc mp fp so 11, 551060; 650-1057, cer bioloxd option hd 36mm, 2907284.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04750; 0001825034 - 2018 - 04751; 0001825034 - 2018 - 04752.

Event Description

It was reported patient underwent an initial left hip procedure.Patient then reported an acute onset of progressive pain and swelling for 6 days following a gastrointestinal illness approximately a month and a half post surgery.Subsequently, patient underwent a hip revision surgery due to pain, swelling, and infection less than 2 months post implantation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of clinical notes.Pre-revision office visit notes confirm that the patient underwent explant of the of the total hip with placement of an antibiotic-coated articulating spacer due to infection.The returned shell component remained assembled with the returned liner.Scratching was observed on the rim of the shell.Foreign material also remained affixed to the shell¿s porous coating.The liner was held firm with no movement allowed in any direction.The inner radius of the liner was scratched and pitted.Gouging was observed on the liner¿s rim.Visual inspection found scratches and gouges on the neck of the stem.Foreign material remained affixed to the porous coating of the stem.No damage was observed on the distal tip of the stem.Visual inspection found scratching on the outer radius and rim of the head.The taper insert of the head was also gouged.A surgical mallet, punch and generic stem were used to remove the taper from the head.No damage was observed on the inside of the taper or the inside of the head.Dhr was reviewed and no discrepancies were found.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.

Event Description

No additional event information to report at this time.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7785407
• MDR Text Key: 117187935
• Report Number: 0001825034-2018-04749
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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: 6229129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 119