MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN MAGNUM ACETABULUM CUP; HIP PROTHESIS

Model Number N/A

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).We are waiting to hear whether the product is available to be returned to zimmer biomet for investigation.Medical product: unknown cobalt chrome head, catalog: unknown, lot: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00547.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient's legal counsel reported that the patient was implanted with an aura ii stem, a crco head and a magnum acetabulum on (b)(6) 2010.Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life.On (b)(6) 2017, the patient fell and the prosthesis has decompensated.It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis.Indeed, it was reported that the metal friction between the prothesis components has led to inflammatory granulomas with a phenomen of bone resorption.On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis.The delay observed between the fall on (b)(6) 2017 and the revision surgery can be explained by the implantation of a total hip prothesis on the left hip.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: unknown cobalt chrome head, catalog: unknown, lot: unknown.Medical product: unknown aura ii stem, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020 -00547-1.As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as item numbers and lot numbers are unknown.A review of the complaint database could not be performed as item numbers and lot numbers are unknown.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Event Description

The patient legal counsel reported that the patient was implanted with an aura ii stem, a crco head and a magnum acetabulum on (b)(6) 2010.Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life.On (b)(6) 2017, the patient fell and the the prosthesis has decompensated.It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis.Indeed, it was reported that the metal friction between the prothesis components has led to inflammatory granulomas with a phenomen of bone resorption.On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis.The delay observed between the fall on (b)(6) 2017 and the revision surgery can be explained by the implantation of a total hip prothesis on the left hip.This report is based on allegations set forth in patients notice and the allegations there in are unverified.This case will not be investigated by legal as the claim is time-barred.

Event Description

It was reported that patient underwent initial right total hip arthroplasty subsequently, the patient was revised approximately 10 (ten) years later due to pain, difficulties, and instability.The patient was reported to have loosening and osteolysis of the acetabular cup as well as osteolysis of the proximal femur with significant bone loss requiring bone grafting and osteosynthesis stabilization during the revision.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Findings: patient had consultation for shoulder and lumbar spine complaints, follow up for neuro assessment post ischemic stroke, chronic low back pain, shoulder pain, weakness and flexion limitation noted in the left (contralateral) hip due to arthritis, no right hip complaints at this time.Patient pursued rehab for post-fall pain in the lower right extremity, pain in the right thigh with feeling of instability, required rehab for several months.Patient had a fall a few years ago (no resulting complications), no limb length inequality, pain in the trochanter, x-rays ordered to assess for possible periprosthetic lesion.Patient reports painful episodes in the right hip, especially when getting in/out of the car, stopped working due to pain.Infection ruled out with aspiration, x-rays show osteolysis, acetabular revision recommended.Left hip surgery also planned due to arthritis.Ct shows right hip osteolysis at the proximal femur with acetabular loosening and osteolysis.X-rays showed a cup tilt of 59°, presence of significant femoral osteolysis led to plans to change out the femoral stem as well.Significant bone loss leading to fracture at the greater trochanter during revision, unknown if during initial implant removal or implantation of competitor product but appears to have been corrected with synthes osteosynthesis stabilization.Appears that the greater trochanter fracture identified in the revision surgery was repaired with synthes plate and cerclage wires, surgery performed to correct a broken pin, no complaint required as this is competitor product.With the available information, 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.

Event Description

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

• Brand Name: UNKNOWN MAGNUM ACETABULUM CUP
• Type of Device: HIP PROTHESIS
• 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: 11027346
• MDR Text Key: 222072412
• Report Number: 3002806535-2020-00546
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 04/27/2023

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: UNK MAGNUM CUP
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/27/2021; 04/07/2023; 04/26/2023
• Supplement Dates FDA Received: 01/27/2021; 04/26/2023; 04/27/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 83 KG