MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 58-60 G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333336
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, a ref xlpe 32 20 deg 58-60 g could not be installed with a ref three hole shell 58mm, although it was tried for an hour in various directions.Surgery was completed, after a delay of an hour, with a s+n back-up device.No harm to the patient or further complications reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The returned device has damage among the base, more than likely from attempted insertion.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.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.According to the inspection procedure, includes verifying parts are free of burrs, pits, sharp edges, nicks or damage areas.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.This event was evaluated through our internal quality process; it was concluded that the surface of the profile is visually damaged due to the attempted implantation.Plastic is easily distorted during attempted implantation, especially when attempting to mate with a rigid surface like the titanium on reflection shells.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: REF XLPE 32 20 DEG 58-60 G
• 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: 13095834
• Report Number: 1020279-2021-08911
• Device Sequence Number: 2047632
• Product Code: JDI
• UDI-Device Identifier: 03596010455697
• UDI-Public: 03596010455697
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 71333336
• Device Catalogue Number: 71333336
• Device Lot Number: 19FM06646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown