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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that during reduction of the hip, the 22 mm femoral head impinged on the anterior rim of the acetabulum, and disengagement of the femoral head from the neck occurred with migration of the metal head over the pelvic brim along the inner table of the pelvis.The decision was made to leave it there, also taking into account the patient¿s age and general condition.The patient and her family were informed about the complication and the decision not to remove the femoral head unless she developed symptoms of compression of vital structures.The postoperative course was uneventful except for serous drainage which lasted for 10 days after the operation, presumably related to the dissection during attempts to remove the femoral head.The patient was walking without pain two months after operation.

Manufacturer Narrative

It was reported from a literature review that during reduction of the hip, the femoral head impinged on the anterior rim of the acetabulum, and disengagement of the femoral head from the neck occurred with migration of the metal head over the pelvic brim along the inner table of the pelvis.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The potential root cause could include but is not limited to user/procedural variance.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9491719
• MDR Text Key: 173271609
• Report Number: 1020279-2019-04493
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

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?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention