MAUDE Adverse Event Report: . MODULAR NECK K 12/14 NECK TAPER; PROSTHESIS HIP

Catalog Number 00784800200

Device Problems Material Erosion (1214); Separation Failure (2547)

Patient Problems Pain (1994); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for 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.Concomitant medical products: item # 00771300500/ modular femoral stem /lot # 62861447.Item# 00801803602 / femoral head sterile/ lot # 62330983.Item# 00620205822 / shell porous/ lot # 62468114.Item # 00630505036/ liner standard/lot # 62476861.Item# 00625006525 / bone screw/ lot # 62463510.Item # 00625006520/ bone screw/lot # 62591548.Item # 00223200418/ cable cerclage cable/lot # 62452802.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021 -00260, 0001822565 -2021 -02233.

Event Description

It was reported that patient was patient underwent a left hip revision surgery 7 years post implantation due pain, osteolysis, elevated metal ions, pseudotumor, and altr.During the revision, significant scar tissue was noted.The shell and stem were well-fixed and left intact.The head and neck came out in one piece.The head, neck and liner were exchanged without further complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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 (b)(4).

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 (b)(4).

• Brand Name: MODULAR NECK K 12/14 NECK TAPER
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): .; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 12442757
• MDR Text Key: 270413521
• Report Number: 0002648920-2021-00261
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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: 05/30/2022
• Device Catalogue Number: 00784800200
• Device Lot Number: 62083772
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention