MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 03/14/2013

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to wear of insert.

Manufacturer Narrative

It was reported that a revision surgery was performed in march 2013 due to wear of insert.As the corresponding hip stem in question (still in vivo) was not sent back for investigation, no functional evaluation could be performed.Furthermore, the part and batch number are unknown and no review of the the production documentation or a complaint history review could be performed.The review of the risk management documentation verified the severity and expected occurrence rate of the reported failure mode.Based on the medical investigation, the initial implants are expected to be a sl plus stem size 4 from s+n, a l-head and a l-plus-cup from ohst and a standard liner, implanted in april 2000.However, from the provided information, it was not possible to determine exactly which stem implant was initially involved.It is known which implants were implanted at the revision surgery.From the intraoperative notes of this surgery, there¿s no indication of the reason or root cause of the wear from the primarily implanted devices.In conclusion, based on the available information, the root cause of the wear that precipitated the revision cannot be concluded.In the s+n hip instruction for use to this time, it is stated that plus hip joint prostheses should only be used in combination with original plus components and in accordance with the product-specific surgical technique.Hence, the stem, assumed to be part of the sl plus family, was maybe not compatible with the ball head of a third party manufacturer at the initial implantation and therefore this cannot be ruled out as a contributing factor to wear, debris and loosening.Based on the conducted investigation for this reported complaint, the root cause of the failure could not be determined conclusively and the need for corrective actions is not indicated.The complaint investigation will be reopened if additional information will become available.Smith+nephew will monitor the device for similar issues.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9304443
• MDR Text Key: 165959809
• Report Number: 1020279-2019-03931
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention