MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNKNOWN

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 10/02/2020

Event Type  Injury  

Event Description

It was reported that initial implantation of a total right hip endoprosthesis was performed in 2001.Revision surgery was performed due to unknown reasons 16 years later (2017) and pe liner was exchanged.Recently, the patient alleged having continual strong pain in the right hip.The metal broken back of the hip cup is radiologically visible (presumably "bicon plus", smith & nephew, size 52) and the pe presumably was found worn out again.The head was found decentered.Another revision surgery was planned for wednesday (b)(6) 2020, though not confirmed yet.

Event Description

It was reported that initial implantation of a total right hip endoprosthesis was performed in 2001.Revision surgery was performed due to unknown reasons 16 years later (2017) and pe liner was exchanged (already covered under case-2021-00036223).Recently, the patient alleged having continual strong pain in the right hip.The metal broken back of the hip bicon plus cup is radiologically visible and the pe presumably was found worn out again.The head was found decentered.Another revision surgery was performed on (b)(6) 2020.The healing process of the patient after the revision surgery was satisfying and x-rays show proper outcome.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10763646
• MDR Text Key: 213913757
• Report Number: 9613369-2020-00224
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/30/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PE INSERT; PE INSERT