MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; HIP PROTHESIS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Cmp (b)(4).Initial report unique identifier (udi) number: (b)(4).Customer has indicated that the product has been discarded and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial surgery that the 36mm ceramic head shattered upon impaction to stem.The surgeon felt that he did not hit the ceramic head very hard.I claimed that he had hit the head much harder in the past without it shattering.

Event Description

It was reported that during an initial surgery that the 36mm ceramic head shattered upon impaction to stem.The surgeon felt that he did not hit the ceramic head very hard.I claimed that he had hit the head much harder in the past without it shattering.

Manufacturer Narrative

(b)(4).As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot combination.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 650-0662.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports implant fracture.Risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states implant fracture.The details of the reported event do not allege that there was any patient harm or delay to surgery.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in the attached rmr.The outcome of the reported event is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11063699
• MDR Text Key: 223357001
• Report Number: 3002806535-2020-00556
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)300420(10)3030855
• Combination Product (y/n): N
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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 Model Number: N/A
• Device Catalogue Number: 650-0662
• Device Lot Number: 3030855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 104