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

Catalog Number 165782

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - stanmore cocr fmrl sz3 std, item 164243, lot 6214972, therapy date - device 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: 3002806535-2018-01253.

Event Description

Study patient s050 had superficial infection.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Unique identifier (udi) number: (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.

Event Description

Study patient (b)(6) had superficial infection after hip replacement procedure.

• Brand Name: STANMORE ACET CUP ARCOM 28X53
• Type of Device: UNKNOWN
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8146885
• MDR Text Key: 129786875
• Report Number: 3002806535-2018-01254
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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: 09/05/2022
• Device Catalogue Number: 165782
• Device Lot Number: 6123353
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1