MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS HI LUBRICER PE INSRT STD 6.11/32; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 75001055

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 07/28/2011

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to change the insert and the ball head after 8 years since primary surgery due to insert wear.Stem ws left in patient.

Manufacturer Narrative

Results of investigation: a revision surgery with exchange of a plus hi lubricer pe insert and a third party ball head due to pe wear was reported.No part was returned for investigation.The documentation available for the reported pe insert was reviewed.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No similar complaint was reported for this batch of products.The available medical documents were reviewed.During implantation, a third-party ceramic ball head was implanted.According to the provided revision report, the pe-inlay is worn towards cranial, the capsule is massively thickened and changed gray.The shell and stem are well integrated and left in-vivo.The provided x-rays dated 4 and 6 years after implantation do not show the pe wear.The patient started having pain 7 years after implantation.The patient is described as fairly active with gardening, fitness, cycling and hiking.Based on the available information, the root cause for the pe wear (uhmwpe) cannot be determined.There is however to the best of our knowledge no indication that the device failed to meet specifications at the time of manufacturing.However, it is to be noted that the use of a third-party ball head and the activity of the patient may have contributed to the reported issue.No further actions have been initiated.If the explants or additional information becomes available in the future this investigation will be reopened.

• Brand Name: PLUS HI LUBRICER PE INSRT STD 6.11/32
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar TN 06340 ; SZ 06340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH500 1; SZ CH5001
• Manufacturer Contact: sarah freestone ; oberneuhofstrasse 10d; baar, TN 06340 ; SZ 06340 ; 0447940038
• MDR Report Key: 7848685
• MDR Text Key: 119321038
• Report Number: 1020279-2018-01720
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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: Health Professional
• Device Catalogue Number: 75001055
• Device Lot Number: 015193
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 93