MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER -3.5 NECK LENGTH; PROSTHESIS, HIPS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial hip arthroplasty.It was reported, one month post operative, an intra prosthetic dislocation (head disassociated from the bipolar liner) occurred.The surgical technique of the product was utilized, and no contributing conditions related to the event.

Manufacturer Narrative

(b)(4).D10: 11-165208 ringloc bi-polar 28x42mm 66081532.G2: foreign: taiwan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided, and a corrected report will be filed under mfr number 2648920 ponce.

• Brand Name: FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER -3.5 NECK LENGTH
• Type of Device: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19059987
• MDR Text Key: 339599469
• Report Number: 0001822565-2024-01181
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 802202801
• Device Lot Number: 66054344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/15/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female