MAUDE Adverse Event Report: BIOMET UK LTD. EXCEED ABT 3HL SHELL 48/60MM

Catalog Number 124860

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - medical product - 36mm 12/14 tpr fem hd std nk, item 650-0888, lot 388226, therapy date - (b)(6) 2017, olympia stem size 5 right, item 650-0635, lot 3220851, therapy date - (b)(6) 2017.Report source, foreign - event occurred in (b)(6).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: 3002806535-2018-01035 and 3002806535-2018-01036.

Event Description

It was reported by the njr that a patient underwent an initial right hip arthroplasty and subsequently, a revision procedure was performed due to infection.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.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.

Event Description

It was reported by the njr that a patient underwent an initial right hip arthroplasty and subsequently, a revision procedure was performed due to infection.

• Brand Name: EXCEED ABT 3HL SHELL 48/60MM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7827251
• MDR Text Key: 118583321
• Report Number: 3002806535-2018-01034
• Device Sequence Number: 1
• Product Code: JDD
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

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 Expiration Date: 12/29/2023
• Device Catalogue Number: 124860
• Device Lot Number: 3200549
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR