MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X 58-60 20DG SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742858
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tha had been performed, a revision surgery was done on (b)(6) 2021 to exchange a ref lnr 28x 58-60 20dg sz g due to wear.As a consequence of the liner removal, the cocr 12/14 fem head 28 -3 was removed too.The current health status of patient is unknown.No further information is available.
Additional Manufacturer Narrative
H3, h6: the associated device was not returned for evaluation and the reported event could not be confirmed, therefore, the contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, it is noted within the attachments no clinical/medical documentation is available.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal similar events for the listed device.A review of the instructions for use document and the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.An historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF LNR 28X 58-60 20DG SZ G
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 13094998
• Report Number: 1020279-2021-08891
• Device Sequence Number: 11829196
• Product Code: LPH
• UDI-Device Identifier: 03596010232281
• UDI-Public: 3596010232281
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2012
• Device Catalogue Number: 71742858
• Device Lot Number: 02EM07376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2002
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71302803/COCR 12/14 FEM HEAD 28 -3
• Patient Sex: Unknown