MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 52MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Biomet liner cat# 110024463 lot#948480.Biomet shell cat# 110010264 lot# 6416655.Biomet stem cat#11-300816 lot#412450.Biomet bearing cat# ep-200148 lot# 764600.Biomet cone cat# 11-301302 lot# 369860.Biomet head cat# 163662 lot# 716520.Report source: (b)(6).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: 0001825034 - 2020 - 00892.0001825034 - 2020 - 00894.

Event Description

It was reported the patient underwent an initial hip arthroplasty.Subsequently, the patient fell and was revised due to liner pulling out of cup approximately 1 month later.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.The following sections were updated/corrected updated: b4, b5, d4, d11, g4, h2, h3, h4, h6.D11: biomet liner cat#010000983 lot#6687372, biomet shell cat#110010264 lot#6416655, biomet stem cat#11-300816 lot#412450, biomet bearing cat#ep-200148 lot#764600, biomet cone cat#11-301302 lot#369860, biomet head cat#163662 lot#716520.Reported event was confirmed by review of medical records/radiographs and picture provided.Review of the available records identified the following: visual examination shows the liner has been disassociated from the shell with the head still assembled.The components show blood stains, no further information can be obtained from the image.Dislocation of the left hip arthroplasty, including the liner.Review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event.A definitive root cause cannot be determined.It was reported that the patient fell however it is unknown if the fall caused or contributed to the disassociation.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: G7 OSSEOTI MULTIHOLE 52MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9762177
• MDR Text Key: 189208903
• Report Number: 0001825034-2020-00894
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• 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: 110010264
• Device Lot Number: 6416655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 72