MAUDE Adverse Event Report: BIOMET UK LTD. UNK G7 BISPHERICAL CUP

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in the (b)(6).The customer has informed zimmer biomet that the device is scheduled for explant on (b)(6) 2022.At this time the customer has not informed zimmer biomet if the device will be returned.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 is enrolled in (b)(6).It was reported that a patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reason is scheduled for (b)(6) 2022.Patient involvement- unknown outcome.

Event Description

It was reported, that: the patient is enrolled in g7-gts rsa study.A patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reason is scheduled for (b)(6) 2022.Patient involvement- unknown outcome.Additional info: 04 feb 2022.¿ inicial surgery (b)(6) 2018.¿ item no: 110017337.Lot: 341123417240923.¿ revision due to loosening.Addi 08 feb 2022.Correct lot is 3411234.Addi 28 feb 2022.Please provide the following information regarding the initial procedure if available: - who was the surgeon for the initial procedure? (b)(6).- at what hospital was the initial procedure performed? (b)(6) hospital.Please provide the following information regarding medical notes and x-rays: find attached.As the product was planned to revised at the start of february 2022, please provide the following information if available: - is the date of revision available? (b)(6) 2022.- what parts were removed (part and lot information if available)? cup and head.- are the parts available for return? the cup is shipped.- were there any complications during the procedure? no.- was there a delay during the procedure? no.- was there any variance from the expected surgical technique? no.Please provide the following patient information if available: - gender: male.- age: 44 years.- weight: 109 kg.- build (underweight, average, obese, etc.): na.- activity level: active.- bone quality: good.- are there any contributing conditions to these complications (i.E.Patient fall, trauma, anatomy, etc.)? no.- did the patient adhere to the rehabilitation protocol after the initial procedure? yes.

Manufacturer Narrative

(b)(4).This follow-up document is being submitted to relay supplemental information.The following sections were amended: a2, a3, a4, b4, b5, b7, d6, g3, g6, h1, h2, h10.Supplemental information acquired: date of revision.Gender.Age.Weight.Activity level.Bone quality.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.

Event Description

25 jan 2022 it was reported that: patient is enrolled in the g7-gts rsa study.A patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reasons is scheduled for (b)(6) 2022.Patient involvement- unknown outcome.Addi 04 feb 2022.Inicial surgery (b)(6) 2018.Item no 110017337 lot 341123417240923.Revision due to loosening.Addi 08 feb 2022.Correct lot is 3411234.

Manufacturer Narrative

(b)(4).This follow-up document is being submitted to relay supplemental information.The following sections were amended: b4, b5, g3, g6, h1, h2, h10.Supplemental information acquired: actual/suspected product data the investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.

Event Description

It was reported that: the patient is enrolled in the g7-gts rsa study.A patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reasons is scheduled for 1-feb-2022.Patient involvement- unknown outcome.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the g7 bispherical acetabular shell was received with the e1 liner still assembled.The outer surface of the acetabular shell presents a few fragments of bone tissue attached to its surface around its circumference, which indicate some degree of bone integration.Some teeth appeared polished or burnished, which may also have been caused by instruments used during revision or by the relative movement of the component with the patient¿s bone, which would confirm the component loosening.Minor scratches and discolouration of the anodized rim of the acetabular shell, likely caused by instruments, a review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.This device is used for treatment.The compatibility assessment shows no issues with the reported devices.A review of complaint history identified one additional similar complaint about the reported item and no additional complaints about the reported item and lot combination it has been confirmed that the instrument/implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.Three anteroposterior radiographs and one mediolateral radiograph were provided: a full-pelvis radiograph taken two days after primary surgery (17-aug-2018), one full-pelvis and one mediolateral radiograph taken approximately 2 years and 4 months after surgery (29-dec-2020) and a hemipelvis radiograph was taken approximately 3 years and 3 months after primary surgery and 2 months before revision surgery (15-nov-2021).The femoral stem appears adequately sized and positioned within the femoral canal, in accordance with the gts surgical technique.Radiostereometric analysis (rsa) markers are visible within the greater trochanter and above the acetabular shell in all provided radiographs.The outer edge of the g7 bispherical shell appears to be not fully supported by bone in the superior region of the acetabulum.Measurements taken suggest that the inclination angle of the acetabular shell may have decreased from approximately 27 degrees two days after surgery to approximately 24 degrees three years and three months after surgery, which may indicate that the component moved with time, thus confirming its loosening.A g7 bispherical acetabular shell, a biolox delta femoral head and a g7 e1 liner were sent to the research department for evaluation after the parts were revised due to loosening of the acetabular shell after approximately 3 years and 5 months in service.The manufacturing history records (mhrs) of the received components, and biolox delta head have been checked and verified that these parts were manufactured and sterilised in accordance with the applicable specifications.Visual examination of the returned g7 bispherical shell and inclination angle measurements from the provided radiographs confirm the reported loosening of the component.Based on the available information, it appears that the low inclination angle of the acetabular shell and subsequent sub-optimal bony coverage of the component may have been contributing factors.The likely condition of the device when it left zimmer biomet is conforming to the specification.The root cause of the reported event cannot be determined with the information provided.Corrective or preventative action is not required as the definitive root cause of the reported event cannot be determined with the information provided.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNK G7 BISPHERICAL CUP
• Type of Device: UNK G7 BISPHERICAL CUP
• 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: 13413062
• MDR Text Key: 284804209
• Report Number: 3002806535-2022-00039
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK G7 BISPHERICAL CUP
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/10/2022; 03/02/2022; 05/23/2022
• Supplement Dates FDA Received: 02/11/2022; 03/16/2022; 05/24/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 109 KG