MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: us157852; lot number: 932370; brand name: m2a-magnum pf cup.Catalog number: 139252; lot number: 764820; brand name: m2a-magnum 42-50mm.Catalog number: 11-103204; lot number: 604530; brand name: taperloc por fmrl.Catalog number: 157446; lot number: 535600; brand name: m2a-magnum mod hd.Multiple reports were submitted along with this report: 0001825034-2022-01851.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain and elevated metal ions approximately 12 years post implantation.During the revision, metal-stained tissue was debrided, pseudotumor was removed, and multiple areas of scar tissue were debrided.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: complication of internal left hip prosthesis ¿ hip pain associated with recalled total hip arthroplasty hardware.Elevated metal ions levels; based on her symptoms and serum iron levels, elected for revision.Prior to reaching the fascia of the gluteus maximus, found pseudotumor- debrided.Metal stained tissue was debrided.Trochanteric bursa had significant inflammatory tissue with minimal metal stained tissue.Debrided scar tissue, substantial amount of scar tissue underneath the gluteus medius anteriorly- debrided.Procedure findings: metallosis.Device history record 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.

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15229467
• MDR Text Key: 297948045
• Report Number: 0001825034-2022-01849
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 932370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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: 59 YR
• Patient Sex: Female