MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71333345
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, a ref xlpe 36 20 deg 54-56 f was not getting locked with the 54 mm od reflection three hole acetabular shell.The shell did fitted and locked appropriately with the trial liner and the replacement liner.Surgery was resumed, after a delay greater than 30 minutes, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The returned liner has damage among the base and locking detail, 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 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 do not have reason to suspect that the product 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.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.D10: add concomitants.G2: report source update.

• Brand Name: REF XLPE 36 20 DEG 54-56 F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12276842
• Report Number: 1020279-2021-06156
• Device Sequence Number: 19762677
• Product Code: LPH
• UDI-Device Identifier: 03596010479754
• UDI-Public: 03596010479754
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 71333345
• Device Catalogue Number: 71333345
• Device Lot Number: 21BM12873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR