MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Us157854 ¿ m2a magnum cup ¿ 337750.239256 ¿ m2a magnum taper ¿ 509280.01.00561.221 ¿ wagner cone stem ¿ 2687668.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02961.

Event Description

It was reported that patient underwent a left hip revision approximately 5 years post implantation due to pain, limited range of motion/mobility, pseudocapsule and metallosis.Fixed magnum acetabular component, black staining of the pericapsular tissue, and clear, yellow synovial fluid was noted.Capsulotomy was performed and a pseudocapsulectomy was performed and the pseudocapsule was sent for frozen sections to assess for metallosis.There was noted to be an abundance of black, staining of the pericapsular tissues.The head and taper were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g4, g7, h2, h3, h6, h10.The event was confirmed with medical records received.Review of the available records identified the following: -failed left total hip arthroplasty with suspected metal hypersensitivity.-anesthesia ¿ regional with sedation.Ebl 100 ml.-left hip pain.It was felt to be secondary to failed bearing surface due to metal hypersensitivity.-removal of metal-metal bearing to alleviate pain and improve ambulatory capacity.-fixed magnum acetabular component, black staining of the pericapsular tissue, and clear, yellow synovial fluid (cultures sent.No report).-capsulotomy was performed and a pseudocapsulectomy was performed and the pseudocapsule was sent for frozen sections to assess for metallosis.There was noted to be an abundance of black, staining of the pericapsular tissues.-the 28+3.5 head with 48/28 poly ball combination was decided upon as this appeared to equalize the leg lengths, provide excellent stability in full standard range of motion testing.-no intra-operative complications.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: remove type of investigation code 4114: device not returned.Upon visual inspection of the returned head, there is damage found on the lip of the device along with scratches on the od.Additional information does not change the outcome of the previous investigation.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.

Event Description

No additional event information to report at this time.

• Brand Name: M2A-MAGNUM HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10333540
• MDR Text Key: 200767869
• Report Number: 0001825034-2020-02962
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 157448
• Device Lot Number: 605180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 02/22/2022
• Supplement Dates FDA Received: 09/11/2020; 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2010
• 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