MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; PRSTHSS, HIP, SMI-CONSTRAIND, MTL/POLYMR, POROUS UNCMNTD

Catalog Number	71742850
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the liner cannot match with the acetabular cup.Then the complaint product was taken out and a backup was used.A 30 min to 1 hr delay was reported.No more information provided yet.
Additional Manufacturer Narrative
It was reported that during procedure the liner cannot seat in the cup.The associated reflection liner was returned and evaluated.A visual inspection of the device noted the splines are slightly damaged.Scratches are observed in the inner diameter of the liner, probably caused by the attempted insertion.A dimensional analysis was conducted which could not confirm the stated failure.All dimensional inspection shows the part to be within spec.As the splines appear damaged at various points and the reading cannot be confirmed as accurate.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REF LNR 28X50-52 20 DEG SZ E
• Common Device Name: PRSTHSS, HIP, SMI-CONSTRAIND, MTL/POLYMR, POROUS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8918538
• Report Number: 1020279-2019-03103
• Device Sequence Number: 514674
• Product Code: LPH
• UDI-Device Identifier: 03596010232267
• UDI-Public: 03596010232267
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Expiration Date: 08/28/2026
• Device Catalogue Number: 71742850
• Device Lot Number: 16HM19830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1