MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71333334
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr surgery, the doctor prepared acetabulum and took a trial of cup size 50.It was good and fixed well so he took the original reflection shell and it fixed well.He then put a 25mm screw for better fixation, then fixed liner for 32 mm head.Later he prepared the femur fix stem and took trial for the head and reduced the hip joint.When he dislocated the hip to put the original head reflection shell, the liner came out and the screw remained inside the bone (it was later removed).He tried to fix it again but did not succeed and then he took size 54 mm.This caused a delay of thirty minutes to an hour.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: REF XLPE 32 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9517193
• Report Number: 1020279-2019-04589
• Device Sequence Number: 11271634
• Product Code: LPH
• UDI-Device Identifier: 03596010455673
• UDI-Public: 03596010455673
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71333334
• Device Catalogue Number: 71333334
• Device Lot Number: 19EM27437
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR