MAUDE Adverse Event Report: BIOMET UK LTD. STANMORE ACET CUP ARCOM 28X53; STANMORE CEMENTED CUP

Catalog Number 165782

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - 28mm mod hd std neck tp1 taper, item 163662, lot j3918636.Therapy date - remains implanted.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: 3002806535-2018-01227.

Event Description

Study patient had suspicion for infection.A re-exploration of the hip and arthrotomy of the hip.

Event Description

Study patient had suspicion for infection.A re-exploration of the hip and arthrotomy of the hip.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Study patient had suspicion for infection.A re-exploration of the hip and an arthrotomy of the hip was performed.

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 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.

• Brand Name: STANMORE ACET CUP ARCOM 28X53
• Type of Device: STANMORE CEMENTED CUP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8118926
• MDR Text Key: 128863207
• Report Number: 3002806535-2018-01228
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Catalogue Number: 165782
• Device Lot Number: 6015864
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2019
• 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