MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS NJ128K; ISODUR PROSTHESIS HEAD 8/10 32MM L

Model Number NJ128K

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 11/04/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Information received from sus voluntary event report (mw5058632): per patient statement on mw5058632: revision surgery required to relieve hip pain, to prevent further bone and tissue destruction, and to avoid metal toxicity.Total hip replacement of the left hip on (b)(6) 2007 due to osteoarthritis.Due to ongoing pain imaging studies were performed and showed a left hip fluid collection.Serum cobalt was 5.1 mcg/l and chromium was 3.1 mcg/l.Revision surgery was performed on (b)(6) 2014 which showed abnormal wear of the plastic liner, synovitis, metal stained granulomatous tissue and a black trunnion.Reported components: na782t / plasmacup fixation screw 6.5x32mm; nc454t / plasmacup sc plasmapore-p size 54mm; nc411t / excia plasmapore-p 8/10 size 11mm; nj128k / isodur prosthesis head 8/10 32mm l; nh203 / sc/msc pe-insert 32mm 52/54 sym.

Manufacturer Narrative

No product is at hand.No product available and therefore an analysis is not possible but we assume the root cause of this failure is not product related.According to the quality standard, a material defect or production error can be excluded.We can not determine the exact cause because there is no product available.No capa is necessary.

• Brand Name: NJ128K
• Type of Device: ISODUR PROSTHESIS HEAD 8/10 32MM L
• 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: 5403131
• MDR Text Key: 37269379
• Report Number: 3005673311-2016-00022
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K042344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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?: No
• Device Operator: No Information
• Device Model Number: NJ128K
• Device Catalogue Number: NJ128K
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/04/2015
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: 01/05/2016
• Supplement Dates FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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