MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER

Model Number	71332525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Paresthesia (4421)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha on (b)(6) 2021, the patient experienced stinging numbing pain down leg when standing.A revision surgery was performed on (b)(6) 2021.During revision surgery, surgeon felt like the acetabular screws may be causing the issue, so he removed both acetabular screws and put in one shorter screw, also liner and head were replaced.The current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, reportedly a revision was performed due to "stinging numbing pain down leg when standing".The requested medical documentation has not been provided as of the date of this medical investigation.Without the requested documentation, the root cause of the reported event could not be fully assessed nor concluded; however, it was reported that both acetabular screws were removed/replaced with one shorter screw, and replaced liner and head.The patient impact beyond the reported events could not be determined, as the current health status of the patient is unknown.No further assessment can be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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 SPHER HEAD SCREW 25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11735866
• Report Number: 1020279-2021-03573
• Device Sequence Number: 14433635
• Product Code: MEH
• UDI-Device Identifier: 03596010460462
• UDI-Public: 03596010460462
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71332525
• Device Catalogue Number: 71332525
• Device Lot Number: 20KB00232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 09/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71332754, LOT:17MM00402; 71343600, LOT: 21AM14765
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention