MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS VITELENE INSERT G 32MM SYM.; HIP ENDOPROSTHESIS

Model Number NV203E

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Inlay could not be appropriately fixed intra-operatively.

Manufacturer Narrative

Investigation: the insert was investigated visually.Furthermore all relevant dimensions were measured in the precision measurement room.Result: the dimensions are within the prescribed tolerances.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably not product related.Possible reason for this failure could be that foreign objects or substances may have deposited in the cup.Rational: on the provided insert, no failures or production deviations could be found, therefore we exclude a product related error.Corrective action according to sop (b)(4) a capa is not necessary.

• Brand Name: VITELENE INSERT G 32MM SYM.
• Type of Device: HIP ENDOPROSTHESIS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5496059
• MDR Text Key: 40432133
• Report Number: 3005673311-2016-00035
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: NV203E
• Device Catalogue Number: NV203E
• Device Lot Number: 52163394
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/29/2016
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: 02/10/2016
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other