MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. CERAMIC INSERT (HI/EP-FIT/MPF); PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN1100101

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 03/31/2012

Event Type  Injury  

Event Description

It was reported that, after a hip replacement in the right side on 1998, the patient felt a cracking in the hip on (b)(6) 2021.The next day the patient felt a crunch and inability to walk.A revision surgery was performed on (b)(6) 2021 to exchange the ceramic insert due to implant fracture.The current health status of patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that after a hip replacement on the right side in 1998, the patient felt a cracking in the hip on (b)(6) 2021.A revision surgery was performed due to a fracture of the ceramic insert.The device, used in treatment, was not returned for evaluation and the part and batch numbers were not communicated, as the patient lost the implant card.Therefore, it cannot be investigated whether the device met specification at the time of manufacturing.The reported severity and the failure mode are covered through the risk management files.The instructions for use lit.No.12.23 ed 05/16 list the reported failure mode among the possible side effects from a total hip replacement.The provided medical images support the reported failure mode.The femoral head is shifting anteriorly and is not centered which is consistent with a broken liner.But no clinical root cause can be concluded.Based on the conducted investigation, a relationship between the reported event and the device can be confirmed.The root cause stays undetermined after investigation as it is not possible to speculate about factors which could have contributed to the reported event.Should additional information become available, this complaint will be reassessed.To date, no further actions are taken.Smith and nephew will monitor the device for further similar issues.

• Brand Name: UNKN. CERAMIC INSERT (HI/EP-FIT/MPF)
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11773400
• MDR Text Key: 249006278
• Report Number: 9613369-2021-00172
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1100101
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 100