MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER LNR 36MM E; G7 CERAMIC LINER

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product has been requested to be returned to zimmer biomet for investigation.Associated products: medical product: tprlc 133 mp 12/14 bm so 11.0.Catalog number: 51-136110.Lot number: 3590312.Medical product: delta cer fm hd 036/+8mm 12/14 catalog number: 650-0667 lot number: 3505837 medical product: g7 finned bm 3 hole shell 52e catalog number: 110017123 lot number: 3578176 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

06 dec 2021: it was reported, that: acetabular implant fracture that took place 5 years after hip replacement surgery.Revision surgery programmed, not yet done.Event reported in the frame of the g7 mdrg2017-89ms-83h study ¿ reported to zb on 06 dec 2021.Patient outcome- implant fracture.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified 2 additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.The associated shell item and ceramic modular head item are compatible with the reported item.It has been confirmed that the implant is not within the scope or subject of any capa, field actions or recalls which could be attributed to reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.

Event Description

06 dec 2021 it was reported, that: acetabular implant fracture that took place 5 years after hip replacement surgery.Revision surgery programmed, not yet done.Event reported in the frame of the g7 (b)(4) study ¿ reported to zb on 06 dec 2021.Patient outcome- implant fracture.

Event Description

It was reported, that: acetabular implant fracture that took place 5 years after hip replacement surgery.Revision surgery programmed, not yet done.Event reported in the frame of the (b)(6)¿ reported to zb on 06 dec 2021.Patient outcome- implant fracture.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified 2 additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.The associated shell item# 110017123 g7 finned bm 3 hole shell 52e and ceramic modular head item# 650-0667 delta cer fm hd 036/+8mm 12/14 are compatible with the reported item.It has been confirmed that the implant is not within the scope or subject of any capa, field actions or recalls which could be attributed to reported event.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Mmi: impressions: 1.Implant fracture with hyperdense fragments superior to the femoral neck.Ct review: an area of metallic density is identified, similar in density to the hip prosthesis, and located in the superior zone of the neck.With 3d reconstructions, we think that this fragment may come from the anterior and medial margin of the cup, where we observed an area of repletion defect or at least more irregular.In addition, this fragment has a concave or "arched" morphology (see volumetric images linked complaint (b)(4)), which could fit in that area.There is another area that is a hole, in the proximal region of the stem, but i think it is a normal image inside the prosthesis, and i find it more difficult to assume that it comes from that side.3 d volumetric reconstructions are sent.A definitive root cause cannot be determined, as the device remains implanted its unknown if the items identified on the ct and in the x-rays are part of the implanted devices or some other debris.

• Brand Name: BIOLOX DELTA CER LNR 36MM E
• Type of Device: G7 CERAMIC LINER
• 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: 13058353
• MDR Text Key: 285537585
• Report Number: 3002806535-2021-00538
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

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: N/A
• Device Catalogue Number: 110003634
• Device Lot Number: 3449636
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 04/05/2022; 04/21/2022
• Supplement Dates FDA Received: 04/05/2022; 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 198 KG