MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cat# 11-165216.Ringloc bi-polar 28x46mm.Lot# 305210.Unknown stem.Unknown cup.Foreign: country: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01247.

Event Description

It was reported the acetabular head luxated from the liner.The liner was removed and replaced.Attempts have been made and no further information has been provided.

Event Description

It was reported the patient underwent a left hip revision approximately 1 month post implantation due to dislocation and disassociation of the bipolar component.Attempts have been made and no further information has been provided.

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: b4, b5, d4, g3, h2, h3, h4, h6 reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) findings: ¿ hip luxation with separation of shell ¿ new shell and liner placed ¿ minimal dictation ¿ per: initial head retained in revision procedure device history record (dhr) was reviewed and no discrepancies were found.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: 28MM DIA COCR MOD HD -3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11726896
• MDR Text Key: 261205988
• Report Number: 0001825034-2021-01248
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163661
• Device Lot Number: 218780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• 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 Age: 76 YR
• Patient Weight: 61