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

Model Number N/A

Device Problems Material Erosion (1214); Noise, Audible (3273)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 03/02/2020

Event Type  Injury  

Event Description

It was reported that approximately eleven years following a hip surgery, a revision surgery took place due to pain, increased metal ions, and a pseudotumor.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4) a2: date of birth - 1945 , d6a: implanted - 2009, g2: foreign - denmark, multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02482.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: a4; b5; b6; b7; g3; h2; h6 corrected: b3; d6; e1 h6: proposed component code: mechanical (g04) - head no product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and review of the identified findings of the reported issues.(jan 2018): cobalt 9.5, chromium 14.5.(oct 2019): cobalt 30.5, chromium 29.0.(nov 2019): ct scan: pseudotumor formation to bilateral hips; pain and audible clunk sounds to left hip; infection rates normal; x-ray: resurfacing on the high side without suspicion of looseness or osteolysis.Nice prosthetic position.On the left side, the bimetric m2a magnum is seen without looseness or osteolysis; exam: tenderness and clear sounds from joint with movement, +1cm leg length; plan: mom left hip with symptoms, elevated metal ions, pseudotumor.Suggestion of revision asap, pt will think about it.A definitive root cause cannot be determined.Complaint is confirmed via medical records.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

It was reported that the patient underwent a revision procedure due to pain, increased metal ions, and a pseudotumor; the head, taper, and cup were revised.The head and taper were revised approximately nine years post-implantation and the cup was revised approximately thirteen years post implantation.During surgery, it was noticed that the taper was cold welded to the head.Attempts have been made and no further information has been provided.

• Brand Name: UNK M2A MAGNUM HEAD
• 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: 18001862
• MDR Text Key: 326448146
• Report Number: 0001825034-2023-02481
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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 Model 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: 10/04/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/29/2024
• 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
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 62 KG