MAUDE Adverse Event Report: BIOMET UK LTD. MLRY-HD 3HOLE RLC SHL 54MM/L24; HIP PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: ringloc-x e1 h/w 54/36mm 24 catalog #: ep-053654, lot #: 3650032, medical product: delta cer fm hd 036/+4mm 12/14 , catalog #:650-0838, lot #: 2016060741, medical product: ti low profile screw 6.5x20mm, catalog #:103531, lot #: 2016030066, medical product: ti low profile screw 6.5x15mm, catalog #:103530, lot #: 2328015.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02093 and 0001825034-2019-02094.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent initial right hip arthroplasty and subsequently was revised approximately two and half years later for cup loosening.

Event Description

It was reported that the patient underwent initial right hip arthroplasty and subsequently was revised approximately two and half years later for cup loosening.

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: MLRY-HD 3HOLE RLC SHL 54MM/L24
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8606952
• MDR Text Key: 144932079
• Report Number: 3002806535-2019-00451
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-104154
• Device Lot Number: 3774190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/15/2019
• 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: 64 YR