MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW; PROSTHESIS HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet g7 dual mobility liner 46mm g, item #: 110024465, lot #: 742780, biomet act artic e1 hip brg 28x46mm item #: ep-200152, unknown lot number, zimmer ms-30â®, stem, standard, cemented, 12, taper 12/14, item #: 300049120, lot#: 2856985, zimmer cocr head 28/-4 's' 12/14, item #: 14280520, lot#: 2902809, zimmer ms-30â®, distal centralizer, cemented, 㸠12/14 item #: 0100351214, lot#: 2860360 report source, foreign - event occurred in (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, because was sent to an external contractor.Review of invoice history was unable to determine the exact identification of the device involved in the reported event.This report is being submitted for: brand name - g7 screw 6.5mm x 15mm, catalog number ¿ 010000996, lot number - 6091320, expiration date ¿ 7/11/2027, (b)(4), device manufacture date - 7/1/2017 or brand name ¿ g7 screw 6.5mm x 35mm , catalog number ¿ 010001000 , lot number - 6077768, expiration date ¿ 6/14/2027, (b)(4), device manufacture date - 6/1/2017, or brand name ¿ g7 screw 6.5mm x 20mm, catalog number ¿ 010000997, lot number ¿ 3181726, expiration date ¿ 10/30/2023 , (b)(4), device manufacture date -10/01/2013.Or brand name ¿ g7 screw 6.5mm x 35mm , catalog number ¿ 010001000, lot number ¿ 3823755 , expiration date ¿ 6/28/2026, (b)(4), device manufacture date -6/1/2016.Or brand name ¿g7 screw 6.5mm x 20mm , catalog number ¿ 010000997, lot number ¿ 6048899, expiration date ¿ 5/2/2027, (b)(4) , device manufacture date -5/1/2017.Reported event was confirmed by review of xrays.Xray review indicated right total hip arthroplasty with broken acetabular cup screw.Transverse fracture right acetabulum.Nonspecific soft tissue mass anterior/lateral to the right hip.Differential considerations for imaging findings include pseudotumor associated with hip arthroplasty and fracture due to granulomatous osteolysis, possible hematoma associated with traumatic hip fracture and osteomyelitis with a weakening of the bone, fracture, and abscess.The large island of heterotopic bone lateral to the right hip.Generalized osteopenia.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 02397 - 1.

Event Description

It was reported a patient underwent hip revision approximately 19 months post-implantation due to pelvic fracture after a fall.Xray review indicated screw fracture.Attempts have been made and no further information has been provided.

• Brand Name: G7 SCREW
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8339218
• MDR Text Key: 136135535
• Report Number: 0001825034-2019-00642
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention