MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS SC/MSC PE-INSERT 32MM 48/50 SYM

Model Number NH202

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 02/10/2015

Event Type  malfunction  

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2015.Mfr'g site evaluation: evaluation on-going.

Event Description

Country of complaint:(b)(6).Patient had a hip replacement (left) in (b)(6) 2008.Suffering from pain in left hip since (b)(6) 2013.Despite several exams no cause could be determined.In (b)(6) 2014, she had an exam; x-ray showed the hip was no longer centered.

Manufacturer Narrative

Manufacturing site evaluation: product was not returned for evaluation.A picture of the polyethylene insert and the metal ball head was provided from the patient.The provided picture shows black areas within the peripheral zone of the insert.Parts of the polyethylene are missing.This was caused by delamination, caused by exceeding the permissible area loading.Investigation of product: product not available, investigation of product could not be carried out.Batch history review: review of batch history indicates no deviations from the valid specifications.Review of the database indicates no other complaints for this batch.Conclusion and root cause edge loading may have led to luxation or subluxation, which resulted in a rubbing between metal parts (ball head and cup), which may have caused metallosis.The most likely root cause for this failure is patient related.The quality and manufacturing documents were reviewed and were found to be according to the valid specifications.There are no other complaints concerning this batch.Therefore a design, product or material failure can be excluded.Corrective action: not required.Product not returned.

• Brand Name: SC/MSC PE-INSERT 32MM 48/50 SYM
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; tuttlingen 78532 ; DA 78532
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; p.o. box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5032911
• MDR Text Key: 24257796
• Report Number: 3005673311-2015-00105
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 12/09/2015

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 Expiration Date: 05/30/2013
• Device Model Number: NH202
• Device Catalogue Number: NH202
• Device Lot Number: 51491998
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2008
• 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