MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGEN/RNGLC+ LTD 50MM SZ 22; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Reaction (2414); Metal Related Pathology (4530)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown ceramic head, unknown stem, unknown biomet liner.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02210, 0001825034-2020-02211, 0001825034-2020-02212.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 pain, metallosis and liner fracture approximately 6 years post implantation.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: prosthetic material is found metallosis that is sent for cultural examination.Pulse lavage notes polyethylene in two fragments plus third smaller fragment.Remove the ceramic head that appears worn.Regenerex cup bottom appears intact.Reported event was confirmed by review of medical records provided.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.H3 other text : device not returned for evaluation.

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.D10: part no:ep-073246 lot no :2824352 brand : ringloc liner.Part no: ps129gp1 lot no :0000748293 brand : gts femoral stem.Part no:650-0835 lot no :2530686 brand :biolox delta head.

Event Description

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

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.This report should be voided, as it was submitted in error.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.This report should be voided, as it was submitted in error.

• Brand Name: REGEN/RNGLC+ LTD 50MM SZ 22
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10115312
• MDR Text Key: 195954340
• Report Number: 0001825034-2020-02211
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2021

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: PT-116050
• Device Lot Number: 146320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 07/02/2020; 04/07/2021; 05/10/2021
• Supplement Dates FDA Received: 07/15/2020; 05/03/2021; 05/13/2021
• 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