MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 68MM I; PROSTHESIS, HIP

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Fall (1848)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient is being considered for a right hip revision due to patient falling and loosening of the cup component.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that patient underwent a right hip revision due to patient falling and loosening of the cup component approximately 7 weeks post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Concomitant medical products: 650-1065 ¿ ceramic taper sleeve ¿ 2948113, 650-1055 ¿ ceramic head ¿ 2959097, 11-301313 ¿ arcos cone ¿ 408090, 11-300924 ¿ arcos distal stem ¿ 527650, 110024466 ¿ g7 dual mobility liner - 983420.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.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigation 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

No additional event information to report at this time.

• Brand Name: G7 OSSEOTI MULTIHOLE 68MM I
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9314644
• MDR Text Key: 166319522
• Report Number: 0001825034-2019-05095
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2020

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 Model Number: N/A
• Device Catalogue Number: 110010272
• Device Lot Number: 6165827
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 11/18/2019; 02/17/2020
• Supplement Dates FDA Received: 12/09/2019; 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK HEAD; UNK LINER; UNK STEM
• Patient Outcome(s): Other
• Patient Age: 63 YR