MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6; PROSTHESIS, HIP

Catalog Number 139252

Device Problems Separation Failure (2547); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Product not returned.

Event Description

Medwatch report states patient underwent a right metal on metal tha and a left tha.Subsequently, patient claims to has had the left hip revised approximately 9 years later due to dislocation and metallosis.Patient also claims to have strange health issues, problems with heart, lungs and skin and fluid build up in both hips.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

D10: ref us157856 lot 436960 m2a shell.Ref 157450 lot 263680 m2a head.Ref 11-104110 lot 061320 mallory stem.

Event Description

It was reported the patient underwent a right total hip arthroplasty.Subsequently, the patient reported that she has experienced swelling in her hips and problems with her heart, lungs, and skin since receiving her total hip.The patient underwent a right hip revision approximately 12 years post implantation due to due to pain and metal related pathology.During the revision, it was found that the adapter was cold welded to the stem and unable to be extracted.An extended trochanteric osteotomy was performed to remove the femoral stem.All components were revised without complication.

Event Description

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

Manufacturer Narrative

Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: findings: metal on metal hip replacement to right hip in 2008.In 2018 started having strange health issues, problems with heart, lungs, and skin.Had fluid build up on hips.Revision due to pain.Extensive fluid consistent with mom arthrosis and sludge.Adapter piece was cold welded to the trunnion.Eto performed to remove the stem due to inability to remove the adapter from the stem, stabilized with cerclage wires.Acetabular component noted to be quite large with bone loss in the posterior wall.All components replaced, no complications.Operative report right periprosthetic femur fracture.Patient returned to the or (b)(6) 2020 due to periprosthetic nondisplaced femur fracture on postop films.During the revision surgery, the surgeon dictated no complications upon removing the zb product and implanted an aml (depuy) stem; after which, he dictated that he found no femoral fractures.As this is a complication post competitor product implantation.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM 42-50MM TPR INSRT-6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9739126
• MDR Text Key: 180409334
• Report Number: 0001825034-2020-00832
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2021

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: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 139252
• Device Lot Number: 545400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/15/2021; 08/11/2021
• Supplement Dates FDA Received: 04/02/2021; 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MAGNUM CUP; UNKNOWN MAGNUM HEAD; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Other