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 Code	Insufficient Information (4580)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case (b)(4).
Event or Problem Description
Us legal.It was reported that plaintiff underwent explantation of the ref spher head screw 25mm.It is unknown if the explantation was performed during the primary left tha or if it was performed during a revision surgery after the primary tha, however the date of the incident was (b)(6) 2019.Plaintiff experienced unspecified injuries.Additional details are unknown.Plaintiff outcome 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, per complaint details, the patient underwent explantation of the acetabular 6.5mm x 25mm cancellous spherical screw with unspecified injuries reported.The requested clinical documentation had not been provided as of the date of this medical investigation.Without the requested clinical documentation, the root cause of the reported event could not be fully assessed or concluded.The patient impact beyond the reported screw explantation could not be determined.No further medical investigation could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12538248
• Report Number: 1020279-2021-07223
• Device Sequence Number: 19189513
• Product Code: MEH
• UDI-Device Identifier: 03596010460462
• UDI-Public: 03596010460462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: R3 MULTI HOLE ACETABULAR SHELL 48MM/UNK; R3 MULTI HOLE ACETABULAR SHELL 48MM/UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female