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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet g7 pps ltd acet shell 54f cat#010000664, lot#6597748; biomet g7 dual mobility liner 44mm f cat#110024464, lot#860080; biomet cer bioloxd option hd 28mm cat#650-1055, lot#2958702; biomet cer option type 1 tpr sleve -6 cat#650-1064, lot#2971089; biomet act artic e1 hip brg 28x44mm cat#ep-200150, lot#956790; biomet tprlc 133 t1 pps ho 18x156mm cat#51-104180, lot#6360473; biomet 3.2mmx20mm rnglc+ acet drl bit cat#31-323220, lot#936380.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03398.

Event Description

It was reported the patient underwent a right tha.Subsequently, the patient reports he had to be revised on the same day due to the cup and liner came loose marring the head.The surgeon stated x rays showed the cup was defective and had come out of the metal part and marred the head.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon visual inspection the shell shows scuffing on the inside of the shell.The ceramic head has a scratch on the metal insert.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.A definitive root cause cannot 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 further event information available at the time of this report.

• 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: 10466014
• MDR Text Key: 204731455
• Report Number: 0001825034-2020-03397
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 6597748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 97