MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN G7 SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Fluid Discharge (2686)

Event Date 11/13/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.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: 0001825034-2018-07179, 07188, 07201, 07224 & 07239.

Event Description

It was reported a patient underwent initial left total hip arthroplasty.Subsequently, patient was noted to have joint effusion approximately two weeks post-implantation.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.

• Brand Name: UNKNOWN G7 SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7764533
• MDR Text Key: 116478808
• Report Number: 0001825034-2018-07201
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA TAPER SLEEVE, CATALOG#: 650-1065, LOT#:; CERAMIC FEMORAL HEAD, CATALOG#: 650-1056, LOT#: NI; TAPERLOC FEMORAL STEM, CATALOG#: 51-107140, LOT#: NI; UNKNOWN G7 ACETABULAR LINER; BIOLOX DELTA TAPER SLEEVE, CATALOG#: 650-1065, LOT#:; CERAMIC FEMORAL HEAD, CATALOG#: 650-1056, LOT#: NI; TAPERLOC FEMORAL STEM, CATALOG#: 51-107140, LOT#: NI; UNKNOWN G7 ACETABULAR LINER
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 57