MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO REV STEM 240MM SZ23 SO; PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT

Model Number	71354713
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgeon was performing a revision hip, removing a bhr cup and emperion stem with bhr modular head.He replaced this with a 76 mm r3 mutlihole shell, a 40 mm zero degree liner and a 23 mm x 240 mm sleeveless redapt stem.During the trialling stage it was found that the shoulder of the stem impinged on the rim of the cup at around the 10 o clock position during abduction and external rotation of the limb.He tried various combinations of head lengths, offset liner and neck options.He feels the cup version is normal and the shoulder of the stem should not impinge at this point.No more information available.
Additional Manufacturer Narrative
It was reported that during the trialing stage of a revision surgery, it was found that the shoulder of the stem impinged on the rim of the cup at around the 10 o'clock positions during abduction and external rotation of the limb.The surgeon feels the cup version is normal and the shoulder of the stem should not impinge at this point.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.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, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Thus no thorough investigation could not be performed.Some potential causes could include but are not limited to surgeon technique not tightening trial body endcap or bone impingement from the greater trochanter.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: REDAPT SLVLS MONO REV STEM 240MM SZ23 SO
• Common Device Name: PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9310022
• Report Number: 1020279-2019-03939
• Device Sequence Number: 2131154
• Product Code: MEH
• UDI-Device Identifier: 00885556579374
• UDI-Public: 00885556579374
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151902
• 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): 06/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71354713
• Device Catalogue Number: 71354713
• Device Lot Number: 17CTM0016C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1