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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #010000864, g7 neutral e1 liner 40mm f, lot #6477896; item #010001034, cocr fem hd 40mm type 1 +3mm, lot #6439479; item #51-106140, tprlc 133 mp type1 pps so 14.0, lot #3653017; 00625006525, bone scr 6.5x25 self-tap, 64175221; 00625006525, bone scr 6.5x25 self-tap, 64158092; 00625006530, bone scr 6.5x30 self-tap, 63635489.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient had an initial right hip arthroplasty.Subsequently, two (2) days post primary implantation the patient was revised due to acetabular defect of the patient which could lead to instability.Additional information was requested, however none was available.

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 forwarded in error and should be voided.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8610044
• MDR Text Key: 145080693
• Report Number: 0001825034-2019-02134
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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: 010000664
• Device Lot Number: 6463593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• 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: 82 YR