MAUDE Adverse Event Report: BIOMET UK LTD. MICRO TAPERLC LAT PC 6MM 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign: event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Associated products.Medical product: delta cer fem hd 032/0mm 12/14, catalog #: 650-0834, lot #: 2018071930; medical product: apical plug, catalog #: 1047-20, lot #: 2018031291; medical product: 56 p+ha rimcup m.C.S.Lin.24, catalog #: 1045-56, lot #: 2018040769; medical product: ringloc-x e1 10deg 54/32mm 24, catalog #: ep-063254, lot #: 6264844.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a revision due to loosening.Subsequently, following the revision of the stem and ceramic head, the surgeon noticed that the stem was not covered with bone, but only the connective tissue.

Event Description

It was reported that a patient underwent a revision due to loosening.Subsequently, following the revision of the stem and ceramic head, the surgeon noticed that the stem was not covered with bone, but only the connective tissue.

Manufacturer Narrative

(b)(4).Radiological image review: the pre-primary radiograph shows loss of articular cartilage in the right hip.The post-primary radiograph shows the taperloc complete microplasty (tcm) stem implanted in the femur.It is not known whether the radiograph was taken just after the primary surgery, during a routine checkup or just before the revision surgery.Radiolucency is observed near the lateral proximal portion of the tcm stem.The inclination angle of the cup could not be measured precisely due to the orientation of the provided picture.However, it was found to be approximately 40 degrees, which is within the 40 to 45 degrees range specified in the surgical technique relevant to the associated acetabular line.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: MICRO TAPERLC LAT PC 6MM 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8892065
• MDR Text Key: 154268697
• Report Number: 3002806535-2019-00664
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00501927929654
• UDI-Public: 0501927929654
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• 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: 650-0971
• Device Lot Number: 6222490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• 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: 46 YR