MAUDE Adverse Event Report: BIOMET UK LTD. MLRY-HD 3HOLE RLC SHL 60MM/L23; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00014 and 0001825034-2019-00015.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left hip replacement surgery on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2018 due to implant wear.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Event Description

It was reported that a patient underwent an initial left hip replacement surgery.Subsequently, a revision procedure was performed due to implant wear.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: taperlc bmpc lat 9.0x137 12/14 catalog #: 650-0562bm lot #: 3312045, medical product: delta cer fm hd 036/-4mm 12/14 catalog #: 650-0836 lot #: 3529937, medical product: rloc-x e1 h/w +3mm 50/36mm 23 catalog #: ep-083650 lot #: 3549268.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

It was reported that a patient underwent an initial left hip replacement surgery.Subsequently, a revision procedure was performed due to polyethylene implant wear.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

• Brand Name: MLRY-HD 3HOLE RLC SHL 60MM/L23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8221788
• MDR Text Key: 132213388
• Report Number: 3002806535-2019-00013
• Device Sequence Number: 1
• Product Code: LZO
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 11-104160
• Device Lot Number: 3200305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• 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: 67 YR