MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71332756
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: case (b)(4).
Event or Problem Description
It was reported that, during a thr the r3 0 deg xlpe acet lnr 36mm x mm56 cannot be anchored in the cup.Look 2-3mm out of the cup.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or other complications were reported.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.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the actual products involved and/or device information, our investigation cannot proceed.If these devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device did not confirm the stated failure mode.A dimensional evaluation of the returned device could not confirm the stated failure mode.The device was found to be within tolerance.A review of complaint history 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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X MM56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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: 11480214
• Report Number: 1020279-2021-02162
• Device Sequence Number: 19690719
• Product Code: JDI
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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,Followup
• Report Date (Section B): 01/05/2022

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: 71332756
• Device Catalogue Number: 71332756
• Device Lot Number: 20KM07189
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 12/29/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 06/18/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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