MAUDE Adverse Event Report: BIOMET UK LTD. G7 BISPHERICAL SHELL 50D; HIP PROSTHESIS

Catalog Number 110017331

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2 - foreign: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that approximately eight years post initial implantation, the patient underwent an acetabular cup revision after persistent discomfort and increasing signs of loosening in the acetabular region found on x-ray.The removed cup showed no sign of bone integration and was completely loosened in the bone acetabular cup bed.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

It was reported that approximately eight years post initial implantation, the patient underwent a revision due to loosening and migration of the acetabular shell.During the revision, it was noted that the shell was completely free of bone with no evidence of ingrowth.The acetabulum was debrided and filled with allograft bone chips.The initial stem was left in place, and all other components were replaced without complication no further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D10 - associated medical devices: forte cer fm hd d36/+4mm 12/14; item# 650-0666; lot# 2015100882.G7 neutral e1 liner 36mm d; item# 010000856; lot# 3770722.Tprloc 12/14 por 10x140; item# 650-0320; lot# 3722357.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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history was performed and found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.The review of the initial op notes identified the following points: ¿ anterolateral minimally invasive approach.¿ no intraop complications identified, minimal dictation provided the review of the revision op notes identified the following points: ¿ aseptic acetabular loosening right hip with migration and bony defect.¿ infection ruled out.¿ stem intact without significant findings.¿ shell is completely free of bone with no evidence of ingrowth.¿ acetabular defects filled with allograft.¿ new shell placed and secured with screws.¿ head and liner placed, initial stem retained.¿ no intraop complications identified.Radiographs were provided and reviewed by a radiologist.The review identified the following points: 1 day post initial op - right hip arthroplasty implants are anatomically aligned.5 years and 4 months post initial op - there is new radiolucency reflecting osteolysis surrounding the medial half of the acetabular cup, which is likely loose.Alignment is maintained.1 day before revision procedure - the radiolucency along the cup is slightly progressed and there is new reactive bone formation along the lateral cup further suggesting cup loosening and motion.There is new mild acetabular protrusio.Alignment is maintained.With the available information, a definitive root cause could not 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.

• Brand Name: G7 BISPHERICAL SHELL 50D
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18969106
• MDR Text Key: 338495396
• Report Number: 3002806535-2024-00109
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 05019279515684
• UDI-Public: (01)05019279515684(17)260315(10)3763630
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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: Lay User/Patient
• Device Catalogue Number: 110017331
• Device Lot Number: 3763630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 50 KG