MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK R2 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number N/A

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); No Information (3190)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown zimmer m/l taper stem, unknown cup, unknown liner, unknown head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01978.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to unknown reasons approximately 6 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately five years post implantation due to chronic dislocations and impingement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: 00801803602 62209912 femoral head sterile product do not resterilize 12/14 taper.00630505836 62179849 liner standard 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell.00620205822 62196455 shell porous with cluster holes 58 mm.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  the following sections were  updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Medical records were provided and reviewed by a health care professional.The patient underwent a revision procedure due to chronic dislocation and impingement.The patient experienced 4 dislocations due to flexion internal rotation type movement.A large trochanteric overgrowth impinged on the lateral aspect of the iliac wing.The head, neck, and liner were replaced and the limb length was extended.It was noted that an additional revision of the contralateral side was necessary due to metallosis.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot 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.

Event Description

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

• Brand Name: MODULAR NECK R2 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10111400
• MDR Text Key: 193426454
• Report Number: 0001822565-2020-01977
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K182676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2020

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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00784804201
• Device Lot Number: 61745801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 09/04/2020
• Supplement Dates FDA Received: 07/02/2020; 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention