MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SIZE 12/14 7.5 ML TAPER EXTENDED NECK OFFSET; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

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

Event Date 11/27/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).D6a implanted date: on (b)(6) 2006.D10: cat#: unknown, lot#: unknown ¿ unknown, durom cup.Cat#: unknown, lot#: unknown ¿ unknown, head.Product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that approximately 18 years post implantation of a total hip arthroplasty, the patient is scheduled for a revision surgery to remove and replace the cup.It was reported that the patient's cobalt and chromium levels are elevated, and the patient has various metallosis issues.A recent mri was reported to also show significant fluid accumulation around the implant.No additional information available.

Manufacturer Narrative

D10: cat# unknown lot# unknown ¿ size 48mm metasul durom acetabular cup cat# unknown lot# unknown ¿ size 42 metasul ldh head cat# unknown lot# unknown ¿ size -4 taper.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01035, 0001825034-2024-01036.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Additional information received that the patient had an initial left total hip arthroplasty approximately seventeen years ago.It was reported that the patient has complaints of pain, tinnitus, skin rash, and a cardiac event reportedly due to metallosis.High metal ions were noted.A large fluid collection on an mri was also noted.Plan for a revision that has not been scheduled.It was reported that events of tinnitus and cardiac issues are related to dehiscence and thinning of the osseous semicircular canals for tinnitus, plaque formation with unconfirmed myocardial ischemia for cardiac event.No additional information available was available.

• Brand Name: UNKNOWN SIZE 12/14 7.5 ML TAPER EXTENDED NECK OFFSET
• Type of Device: PROTHESIS, 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: 19122279
• MDR Text Key: 340338344
• Report Number: 0001825034-2024-01037
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White