MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX PROSTHESIS HEAD 12/14 28MM S; HIP ENDOPROSTHESES

Model Number NK460

Device Problem Fracture (1260)

Patient Problem Missing Value Reason (3192)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Fourteen year post operative fracture of prothesis head.Patient felt a cracking while getting up and a grind in motion.X-ray indicated ceramic fracture.During the revision the fragment of the ceramic head was recovered.Prosthesis remained in place; the inlay and head were changed.Components involved: nh052t / plasmacup sc size 52mm / 51128646; nk662t / antega plasmapore 12/14 size 12mm right / lot number 51126259 (not marketed in the u.S.); nh093 / sc/msc ceramics insert 28mm 52/54 sym./ lot number 51110562 (not marketed in the u.S.).

Manufacturer Narrative

Explants were not received for investigation.Due to a lack of fragments and information about the laser engraving, the identification of the complained ball head is only possible based on the information provided.With this information the complained ball head could be limited to shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the values obtained on the ball head were according to the specification valid at the time of production.The ball head properties and the microstructures as obtained from the quality documents accomplish the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Due to a lack of ceramic parts further investigations can not be done.The evaluation of the ceramic component is based on the investigation of the manufacturer of the broken ceramic ball head (company (b)(4)).Data is filed under (b)(4).

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: HIP ENDOPROSTHESES
• 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 ; 3145515988
• MDR Report Key: 5571904
• MDR Text Key: 42490123
• Report Number: 3005673311-2016-00048
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060918
• 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: 06/23/2016

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: No Information
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51110563
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/04/2016
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2001
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 70