MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Cyst(s) (1800); Pain (1994); Local Reaction (2035); Tissue Damage (2104)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801804002 ¿ cocr head ¿ 61247014.00620205822 ¿ trabecular metal shell - 61120973.00625006525 ¿ bone screw ¿ 61238577.00625006530 ¿ bone screw ¿ 61197915.00630505840 ¿ xlpe liner ¿ 61250222.00771301500 ¿ m/l taper stem - 60850474.Customer has indicated that the product will not be returned to zimmer biomet for the 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00323.0001822565 - 2020 - 02287.

Event Description

It was reported that patient underwent a left hip revision approximately 5 years post implantation due to malpositioning of the stem shell, pain and tissue damage.During the surgery, large fluid collection was noted anteriorly with a portion of the cyst cavity sent to pathology.Adverse response to metal debris and local inflammation with chronic irritation of the iliopsoas tendon was also noted.The stem was well fixed and required an extended trochanteric osteotomy to be removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records noting patient underwent an initial left tha on (b)(6) 2009 with no intraoperative complications noted.The patient underwent a revision of the left tha on (b)(6) 2014 due to malpositioning, pain, and tissue damage.Xrays leading up to the revision indicated mild retroversion of the acetabular component and heterotopic bone around the left hip.During the revision, a large fluid collection was noted anteriorly.The stem was well fixed and required extended trochanteric osteotomy to remove.The acetabular component was noted to have significant retroversion; the modular stem was noted to have mild retroversion.Noted adverse tissue response to metal debris and local inflammation with chronic irritation of the iliopsoas tendon.Large amount of redundant cystic material presented itself in the joint.All components were explanted and new components were placed without complication.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03307.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: M/L TAPER NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10206226
• MDR Text Key: 197202032
• Report Number: 0001822565-2020-02286
• Device Sequence Number: 1
• Product Code: LPH
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00784802200
• Device Lot Number: 60898630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 89