MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 15X155MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pain (1994); Ambulation Difficulties (2544); Cancer (3262)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01441, 0001825034 - 2018 - 01442, 0001825034 - 2018 - 01443.Concomitant medical products: 163674 32mm cocr mod hd +6mm no skirt lot 435090, 010000668 g7 pps ltd acet shell 62h lot 3730862, 010000735 g7 neutral arcomxl lnr 32mm h lot 3280529.Report source: foreign.The event occurred in (b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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.Not returned to manufacturer.

Event Description

It was reported that the patient experienced moderate to severe pain with occasional use of pain medication stronger than aspirin, moderate limping that required support, difficulty performing usual daily activities, pain that interfered with usual work, and an unsatisfactory rating three months post op.Subsequently, it was reported that the patient was lost to follow up due to death from aggressive lung cancer.No further information provided.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.X-rays were reviewed and found the following: left total hip arthroplasty is present.No radiographic features are present definitely predisposing to hip dislocation.Orientation of acetabular cup abduction and inclination appear to be within the "safe zones" (cup inclination and anteversion of 40° ± 10° and 15° ± 10°, as defined by lewinnek).Femoral stem component orientation also appears acceptable.The patient's bone condition appears normal.Dhr was reviewed and no discrepancies were found.Root cause could not be determined with information available.Contributing factors to the 3 month pain is the 2nd dislocation that was said to have occurred during that time frame.This is however unconfirmed because there is no evidence of dislocation and an unknown date.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: ECHO POR FMRL LAT NC 15X155MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7295882
• MDR Text Key: 100908858
• Report Number: 0001825034-2018-01440
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 192115
• Device Lot Number: 002020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 115