MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK S 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Tissue Damage (2104); No Information (3190)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer liner cat#unk lot#unk, zimmer cup cat#unk lot#unk, zimmer head cat#unk lot#unk, zimmer stem cat#unk lot#unk.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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 -00007, 0001822565 -2020 -00047.

Event Description

Patient¿s legal counsel reported patient underwent right total hip arthroplasty.Subsequently patient underwent a revision procedure approximately 9 years later due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 patient underwent initial right total hip arthroplasty.Subsequently, the patient was revised approximately nine (9) year later due to pain, altr, pseudotumor, and elevated metal ion levels.During the revision, it was found that the acetabular shell was excessively anteverted with impingement of the femoral stem against the liner causing a fracture of the liner.Significant corrosion was noted on the femoral head and neck trunnion.The shell, liner, head, and neck were replaced without complication.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: a2, a3, a4, b1, b5, b6, b7, d1, d2, d4, d11, g4, g5, h1, h2, h3, h4, h6, h10.D11:ref 00771301100 lot 61329199 stem size 11, ref 00620005422 lot 61374971 shell 54mm, ref 00630505036 lot 61369377 longevity liner 36mm 3.5mm offset, ref 00784800300 lot 61190313 kinectiv neck s, ref 00801803602 lot 61424867 versys head 36mm+0.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00007, 0001822565 - 2020 - 00047, 0002648920 - 2020 - 00042, 0002648920 - 2020 - 00043.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 reported event was confirmed with medical records provided.Revision op notes demonstrated that the patient was revised due to pain, altr, pseudotumor, and elevated metal ion levels.During the revision, it was found that the acetabular shell was excessively anteverted with impingement of the femoral stem against the liner causing a fracture of the liner.Significant corrosion was noted on the femoral head and neck trunnion.The shell, liner, head, and neck were replaced without complication.The torn gluteus medius tendon was also repaired.Review of the device history record(s) for identified no deviations or anomalies during manufacturing related to the reported event.Additional information does not affect the root cause.Root cause was unable to be determined.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.

• Brand Name: MODULAR NECK S 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9554332
• MDR Text Key: 173915967
• Report Number: 0001822565-2020-00048
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2020

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: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 00784800300
• Device Lot Number: 61190313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/07/2020; 01/21/2020; 04/16/2020
• Supplement Dates FDA Received: 01/09/2020; 02/13/2020; 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84