MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 32MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: stem: 0001825034-2019-00232; head: 0001825034-2019-00233; cup: 0001825034-2019-00234.

Event Description

It was reported that the patient underwent right hip arthroplasty and subsequently, 2 1/2 years later it was reported that the patient suffered pain and limping.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Age or date of birth: unknown month and day in 1946.Udi: (b)(4).Concomitant medical products: part: 192110, echo por fmrl lat nc 10x130mm, lot: 128290, part: 163670, 32mm mod head cocr +3mm neck, lot: 00j3564882, part: 010000666, g7 pps ltd acet shell 58g, lot: 3863698, part: 010000734, g7 neutral arcomxl lnr 32mm g, lot: 3273067.Report source : finland.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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

It was further reported the patient had a gluteus medius rupture and had to use an assistive device for limp to ambulate.Attempts have been made and no further information has been provided.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 32MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8264518
• MDR Text Key: 133696667
• Report Number: 0001825034-2019-00238
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000734
• Device Lot Number: 3273067
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2019
• 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: 72 YR
• Patient Weight: 90