MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 10X130MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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 patient is experiencing trochanteric bursitis and is unable to bear weight approximately three months post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b))(4).D10: acetabular cup 010000664, lot 6840429 acetabular liner 20113606, lot 64617991 femoral head 6500660, lot 3030957 g2: mymobility clinical study: 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

It was reported that the patient had an initial right tha and within three months was experiencing trochanteric bursitis and is unable to bear weight.The patient continued to experienced moderate-severe pain at the three month follow up leading to mri and aspiration of the right hip.Results/outcome pending.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of medical records noting patient presented with pain while bearing weight.Trochanteric bursitis was noted along with numbness lateral to incision.Dhr was reviewed and no discrepancies were found.The root cause is 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.

Event Description

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

• Brand Name: ECHO POR FMRL LAT NC 10X130MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11285501
• MDR Text Key: 230469189
• Report Number: 0001825034-2021-00382
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192110
• Device Lot Number: 103690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 05/07/2021
• Supplement Dates FDA Received: 04/29/2021; 05/11/2021
• 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): Other
• Patient Weight: 100