MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS VITELENE INSERT F 32MM POST.WALL; IMPLANTS PLASMAFIT

Model Number NV302E

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Post Operative Wound Infection (2446)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).The patient received an inlay revision surgery on (b)(6) 2017.After a short time this inlay showed strongly deformations which made a new revision surgery necessary.Total hip replacement (thr) (b)(6) 2016.Revision surgeries performed: revision (b)(6) 2017 due to infection, change of inlay (nv302e) and head, revision (b)(6) 2017 due to recurring luxation.

Manufacturer Narrative

Aesculap inc.(importer) is submitting this report on behalf of aesculap ag (manufacturer).Exemption number: e2014018.Manufacturing site evaluation: evaluation on-going.Additional information: single use.

Event Description

Country of complaint: (b)(6).The patient received an inlay revision surgery on (b)(6) 2017.After a short time this inlay showed strongly deformations which made a new revision surgery necessary.Total hip replacement (thr) (b)(6) 2016.Revision surgeries performed: revision (b)(6) 2017 due to infection, change of inlay (nv302e) and head.Revision (b)(6) 2017 due to recurring luxation.

• Brand Name: VITELENE INSERT F 32MM POST.WALL
• Type of Device: IMPLANTS PLASMAFIT
• 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
• MDR Report Key: 6882840
• MDR Text Key: 88161713
• Report Number: 9610612-2017-00467
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122783
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: NV302E
• Device Catalogue Number: NV302E
• Device Lot Number: 52217926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/14/2017
• Device Age: 17 MO
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR