MAUDE Adverse Event Report: AESCULAP AG SC/MSC BIOLOX DELTA INS.28MM 44/46 SYM.; HIP PROSTHESIS

Model Number NH091D

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigaiton on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a patient experienced a fracture of the biolux delta and the inlay 6 years 7 days after the device was implanted.Original surgery (implant) date was (b)(6) 2012.Concomitant devices include the following: nh346t / plasmacup nsc size 46mm / lot number: 51837700; nc280t / metha cap 12/14 135°/0° size 0 / lot number: 51520574; nk462d / biolox delta prosth.Head 12/14 28mm l / lot number: 51851776 (second medwatch report filed for this component).All medwatch reports associated with this incident include the following: 9610612-2018-00453; 9610612-2018-00454 (this report).

• Brand Name: SC/MSC BIOLOX DELTA INS.28MM 44/46 SYM.
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlinggen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlinggen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7928163
• MDR Text Key: 122444584
• Report Number: 9610612-2018-00454
• 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: 10/02/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: NH091D
• Device Catalogue Number: NH091D
• Device Lot Number: 51852511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Distributor Facility Aware Date: 09/28/2018
• Device Age: 6 YR
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR