MAUDE Adverse Event Report: BIOMET UK LTD. RINGLOC-X E1 H/W 54/32MM 24; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 09/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001825034 - 2017 - 11151, 0001825034 - 2017 - 11152, 0001825034 - 2017 - 11153, 0001825034 - 2017 - 11154, 0001825034 - 2017 - 11155, 0001825034 - 2017 - 11156.(b)(4).Report source: foreign - the event occurred in (b)(6).Device remains implanted.

Event Description

It was reported the patient was prescribed antibiotics for 11 days to address wound drainage post-primary hip replacement.The outcome was considered resolved.No further information has been made available.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were 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.

• Brand Name: RINGLOC-X E1 H/W 54/32MM 24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7282688
• MDR Text Key: 100441824
• Report Number: 3002806535-2018-00365
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-053254
• Device Lot Number: 3276013
• Other Device ID Number: SEE H10 NARRATIVE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 140