MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333324
Medical Device Problem Codes	Defective Device (2588); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during thr procedure the 28 mm liner was not compatible with reflection shell size 50.Tried multiple times but failed to fit.No delay in surgery time since 32 mm liner was available, it was very smooth to fit in the first try.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that the size 28mm liner did not fit with the size 50 shell, after multiple attempts.Per complaint details, a size 32mm liner was used, and fit on the first try with no delay or patient injury.Therefore, no further assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Potential probable causes could be but are not limited to the stem is larger or smaller than the trial or broach when implanting, improper size of device used, surgical technique, unclear user instruction, and procedural/user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF XLPE 28 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10312357
• Report Number: 1020279-2020-03446
• Device Sequence Number: 19391904
• Product Code: JDI
• UDI-Device Identifier: 03596010455611
• UDI-Public: 03596010455611
• 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): 07/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71333324
• Device Catalogue Number: 71333324
• Device Lot Number: 19LM07471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention