MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN TI PF FEM COMP SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71306814
Date of Event	12/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during total hip arthroplasty, after using synergy tool of no.14, the position and stability was suitable.After that, using no.14 stem, the installation gap is 1.5 cm, and it could not be implanted.After 30 minutes, a no.13 stem was used to complete the surgery.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned stem was completed but could not confirm the stated failure.There is minor damage where the inserter is used.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 document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: the seven undated, unlabeled x-rays provided of the left and right hips were reviewed and do not provide insight into the reported intra-operative event.Without the requested clinical information or the implantation report the root cause of the reported connection issue cannot be determined.The device was not returned, however, the evaluation of the provided photos of the implants and the dhr confirmed there were no manufacturing abnormal that could have contributed to this event.Therefore, a procedural variance cannot be ruled as the likely cause of the reported event.Per report, the procedure was completed with a no.13 stem and there was no harm reported to the patient as a result of the 30-minute delay.Since it was reported the patient is out of the hospital in good condition, no further clinical/medical assessment is warranted at this time.This device is an implant.Some potential probable causes for this event could include but is not limited to, 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 warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SYN TI PF FEM COMP SZ 14
• 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: 11167623
• Report Number: 1020279-2021-00360
• Device Sequence Number: 14230853
• Product Code: LPH
• UDI-Device Identifier: 03596010194688
• UDI-Public: 03596010194688
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963509
• 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): 06/29/2021

1 Device 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: 71306814
• Device Catalogue Number: 71306814
• Device Lot Number: 19CM04874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/25/2020
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No