MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX DELTA PROSTH.HEAD 12/14 32MM M; MPLANTS STANDARD PROSTHESES HEADS

Model Number NK561D

Device Problem Contamination (1120)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: according to the provided information, an impurity can be found inside the taper of the ceramic ball head.A hair bristle can be detected inside the taper of the ceramic ball head.The ceramic ball head has been inspected optically.The mentioned failure pattern can be confirmed.The device history records have been checked and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number.The capa is not necessary.

Event Description

Country of complaint: (b)(6).Intraoperatively opened implant was dirty.In the inner packaging, the implant was / is a foreign body, looks like a bristle.

• Brand Name: BIOLOX DELTA PROSTH.HEAD 12/14 32MM M
• Type of Device: MPLANTS STANDARD PROSTHESES HEADS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7562293
• MDR Text Key: 109832168
• Report Number: 9610612-2018-00222
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082991
• 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
• Report Date: 06/01/2018

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: Health Professional
• Device Model Number: NK561D
• Device Catalogue Number: NK561D
• Device Lot Number: 52413563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Distributor Facility Aware Date: 05/17/2018
• Device Age: 3 MO
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other