MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 0 DEG 46-48 SZ D; PRSTHESIS, HIP, SEMI-CONSTRAINED, MTAL/POLYMER, PRUS UNCMNTD

Model Number 71333373

Device Problem Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 10/07/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to dislocation, because of wear.The patient requires abrasion loss of the liner.

Manufacturer Narrative

It was reported that revision surgery was performed due to dislocation, because of wear.The affected devices, used in treatment, were returned and evaluated.A lab analysis conducted during this investigation noted that examination of the od of the shell revealed tissue on growth which appears to be bone.The inside of the shell does not exhibit any unexpected wear or scratches.The femoral head does not display any markings of damage resulting from a dislocation.The hole cover and screws do not have any noted physical changes which would indicate they played a part in a dislocation.Examination of the od of the poly does not show any abnormal wear.A yellow tint can be seen, this likely is due to absorption of bio-logical fluids over the time of implantation.The id does not show any abnormal wear or marks of neck impingement that would be expected in the presence of dislocation.The head appeared to be tight with no evidence of wear as reported.This visual analysis of the returned devices does not support the reported statement of dislocation due to wear.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship between the devices 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.Per e-mail communication the devices had been implanted for 10 years.Possible causes could include but not limited to lifetime of device or device friction.Based on this investigation, the need for corrective action is not indicated.We will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF XLPE 28 0 DEG 46-48 SZ D
• Type of Device: PRSTHESIS, HIP, SEMI-CONSTRAINED, MTAL/POLYMER, PRUS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9397079
• MDR Text Key: 168673706
• Report Number: 1020279-2019-04234
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010455857
• UDI-Public: 03596010455857
• Combination Product (y/n): N
• PMA/PMN Number: K002747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/27/2016
• Device Model Number: 71333373
• Device Catalogue Number: 71333373
• Device Lot Number: 06KM02575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NO.: 11915 / LOT NO.: 07DM19709; PART NO.: 71330001 / LOT NO.: UNKNOWN; PART NO.: 71336048 / LOT NO.: 07DM11210; PART NO.: 71336525 / LOT NO.: UNKNOWN (2 DEVICES)
• Patient Outcome(s): Required Intervention