MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP,SEMI-CONSTRAINED,METAL/POLY,CEMENTED

Model Number	71337652
Medical Device Problem Codes	Positioning Failure (1158); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported during a procedure the r3 20 deg xlpe acet lnr 32mm x 52mm did not lock into r3 coated shell during impaction.The acetabular liner was replaced with a new one.The procedure had a delay between 0-30 min.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device shows no major damage on the part.The dimensional evaluation concluded that critical features for the returned product were evaluated for conformance to drawing print requirements.Of the measured features, two feature were out of tolerance ¿ internal spherical radius and outer profile.The clinical/medical evaluation concluded that this case reports that during a primary hip replacement, the r3 liner did not lock into the shell during impaction.The liner was removed and another liner (same part number; different lot number) was then implanted.Per complaint details, there was no patient harm, and a minimal surgical delay reported.No further clinical assessment is warranted.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The contribution of the device to the reported event could not be corroborated.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.This event was evaluated through our internal quality process, the evaluation concluded that the surface of the part is visually damage and out of tolerance features are due to the attempted implantation.Plastic is easily distorted, especially when attempting to mate with a rigid surface like the titanium on r3 shells.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 52MM
• Common Device Name: PROSTHESIS, HIP,SEMI-CONSTRAINED,METAL/POLY,CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10938578
• Report Number: 1020279-2020-06931
• Device Sequence Number: 4258973
• Product Code: JDI
• UDI-Device Identifier: 03596010598493
• UDI-Public: 03596010598493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: 71337652
• Device Catalogue Number: 71337652
• Device Lot Number: 12CM13563
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown