MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 60MM G; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: g7 neu +5mm arcomxl lnr 40mm g, pn 110017192, ln 6448325, g7 neu +5mm arcomxl lnr 40mm g, pn 110017192, ln 6384210.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05239, 0001825034-2019-05240.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 underwent a revision of an unknown product due to unknown reason.During the revision procedure the surgeon used a g7 osseoti cup and arcos stem.After trialing it was determined that a +5 g7 liner was the most stable construct.Surgeon tried to impact liner into cup and liner would not seat.Cup cleaned multiple times, screws checked, different size ball impactors were used.Liner would not seat.Opened a new liner; new liner would not seat.Surgeon decided to abort to dual mobility liner.Dual mobility liner seated without incident.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).

Event Description

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

Event Description

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

Manufacturer Narrative

D4 (udi): (b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b2; b4; b5; d4; d6; d10; g4; g7; h1; h2; h3; h6.Upon visual inspection both of the liners did not show any damage to the outside radius of the sphere.The scallops on both of the liners show an indentation along with the chamfer seen on the print.Device history record (dhr) was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) mmi review: right total hip arthroplasty with horizontal positioning of the acetabular cup as well as acetabuli protrusio and absence of the medial wall, suggesting migration.Rounded lucency along the inferior acetabulum laterally suggests possible osteolysis.Significant lucency along the femoral stem suggests possible loosening of the femoral component.Horizontal alignment of the acetabular cup is abnormal.Acetabular inclination angles cannot be accurately measured without a true ap pelvis film.However, visually, the acetabular cup appears to be horizontal in position.Significant lucency along the femoral component suggests loosening.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).This report is being submitted to relay additional information.The following sections have been updated.

Event Description

It was reported the patient underwent a primary tha.It was noted during the procedure the original g7 +5 liner would not seat within the g7 osseoti cup.After multiple attempts to seat the liner unsuccessfully, the decision was made to try a new liner and check the cup/screws.Visually the cup and screws were checked, the new g7 +5 liner still would not seat.At this point, the surgeon made the decision to proceed utilizing a g7 dual mobility liner which seated without incidence.The procedure was completed following a thirty-minute delay d/t multiple forceful events at seating the two primary liners.The patient was later determined to have a acetabular fracture where the g7 cup pushed through the medial wall.The surgeon believes he may have cracked the pelvis during the primary surgery while attempting to seat the g7 liners.Subsequently, the patient underwent an acetabular revision where the cup, bone screws, dual mobility liner and ceramic head were revised.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 60MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9367476
• MDR Text Key: 206879690
• Report Number: 0001825034-2019-05241
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• 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: 110010248
• Device Lot Number: 6340025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• 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 Weight: 60