MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 650-0662 ¿ delta ceramic head ¿ 6425438; 010000998 ¿ g7 screw ¿ 6814773; 010000998 ¿ g7 screw ¿ 6925871; unknown cup ¿ unknown part and lot; unknown stem ¿ unknown part and lot.Report source (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient presented with recurring dislocations and underwent a hip revision approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information provided by the customer.Review of photos provided shows a head and liner and marks consistent with usage of device.Dhr was reviewed and no discrepancies were found.The root cause is 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 NEUTRAL ARCOMXL LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11991570
• MDR Text Key: 255945834
• Report Number: 0001825034-2021-01773
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524995
• UDI-Public: (01)00880304524995(10)3076327(17)180801
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 010000742
• Device Lot Number: 3076327
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• 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