MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ISODUR PROSTHESIS HEAD 12/14 32MM M; HIP PROSTHESIS

Model Number NK530K

Device Problem Material Fragmentation (1261)

Patient Problem Missing Value Reason (3192)

Event Date 05/04/2016

Event Type  Injury  

Event Description

Country of complaint: (b)(6).One month post operative revision surgery due to metal abrasion in tissue.Involved components: nh203 / sc/msc pe-insert 32mm 52/54 sym./ lot number 52211724 / manufacture date 02/10/2016 / expiration date 12/31/2020.

Manufacturer Narrative

Investigation: due to the fact that we did not receive all components which were implanted in the first surgery ((b)(6) 2002) and also no information concerning item number/ batch number it is not clear which components were combined.Radiology reports/ x-ray pictures from (b)(6) 2016 which were available, do not provide any information about the fitting position of the primary surgery.The available cup was investigated visually and microscopically.The inner surface shows significant wear marks and metal abrasion.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.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 these batches.Conclusion and root cause: based on the information available as well as the results of our investigation the root cause of the failure is most probably not product related.It could be determined that the metallosis was already known by the time of the first revision surgery on (b)(6) 2016.We assume that the pe inlay has loosened from the nh054t plasmacup (this is also mentioned in the surgery report).According to the product management it is possible that the pe insert can be released respectively can be tilted within this time span (implantation (b)(6) 2002 till first revision operation (b)(6) 2016), when being loosened and not positioned properly.Due to the incorrect position of the insert inside the cup, the ball head comes into direct contact with the metal cup.The resulting metal on metal situation most probably lead to metal abrasion.In this context we would like to point out that the known and present implant component from primary surgery on (b)(6) 2002 (nh054t plasmacup sc size 54 mm with lot 51126507) which was investigated is not responsible for the failure.The statement of the user, that there was a metal abrasion within four weeks, could not be confirmed.Corrective action: according to sop (b)(4) a capa is not necessary.

• Brand Name: ISODUR PROSTHESIS HEAD 12/14 32MM M
• Type of Device: HIP PROSTHESIS
• 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: 5759352
• MDR Text Key: 48456566
• Report Number: 3005673311-2016-00091
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040191
• 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: 04/03/2017

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: NK530K
• Device Catalogue Number: NK530K
• Device Lot Number: 52180156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/07/2016
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• 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
• Patient Age: 71 YR