MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEMORAL HEAD IMPL; PRSTHSS,HP,HM-,TRNNIN-BRNG,FMRL,MTL/POLYACETAL

Catalog Number UNKNOWN

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 05/15/2020

Event Type  Injury  

Event Description

Acetabular liner dissociation: a case report and review of the literature".Author: asif a.H.Parkaret al., edp sciences, 2019.It was documented on the paper that a (b)(6) patient had a tha performed using the smith & nephew r3 size 60 acetabular shell with 60/36 highly cross-linked polyethylene liner in the templated position.However, 5 years after the primary operation, the patient had a fall and presented with a new onset of hip pain.Evaluation of the radiographs showed a polyethylene liner dissociation (pld).A revision surgery was performed, the femoral component was stable and therefore retained.Surgery involved replacement of liner due to dislocation.In addition, the acetabular shell and the femoral head along with excision of a pseudo tumour resulting from metallosis were also removed, this was due to contact of the femoral head with the acetabular metal shell.This event has been reported under mdr 1020279-2020-03068.The definitive components implanted included competitor devices zimmer continuum shell of size 64 mm with an offset liner and 36 mm + smith and nephew 12 oxinium femoral head.The patient presented with a another dislocation of his tha within a month of his first revision operation.He underwent closed reduction under general anaesthesia but unfortunately, continued to have persistent instability, and hence a month later the patient underwent a second revision.Intraoperatively, the components were reassessed and it was confirmed that both the acetabular shell and femoral stem were well fixed in excellent position and therefore both components were retained.The competitor polyethylene was revised and a constrained liner was used instead with a new size of 36 mm + 12 oxinium femoral head.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.Therefore, no further interpretation of the attached x-ray(s) is required, and no further medical assessment is warranted at this time.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN FEMORAL HEAD IMPL
• Type of Device: PRSTHSS,HP,HM-,TRNNIN-BRNG,FMRL,MTL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10259891
• MDR Text Key: 198500355
• Report Number: 1020279-2020-03069
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECHELON PP HA SZ 15 190MM / PN:71342015
• Patient Outcome(s): Hospitalization; Required Intervention