MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 190MM STR SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71340111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken component.The previous revision surgery was performed on (b)(6) 2016.On (b)(6) 2019, the patient complained that femoral stem was broken.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that the root cause of the loosening and pain which resulted in the first revision was most likely secondary to micro-motion over an extended period of time as evidenced by the cortical thickening and radiolucent line around the stem, but this could not be definitively concluded based on the imaging alone (previous revision surgery).The root cause of the fractured stem, which resulted in the second revision, could not be concluded based on the imaging alone but loosening and the resulting micro-motion was again the likely root cause (reported revision surgery).The patient impact beyond the reported pain, loosening, and the two revision procedures could not be determined.No further medical assessment can be rendered at this time.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.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include but are not limited to loosening or improper device fit / sizing.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 warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that the root cause of the loosening and pain which resulted in the first revision was most likely secondary to micro-motion over an extended period of time as evidenced by the cortical thickening and radiolucent line around the stem, but this could not be definitively concluded based on the imaging alone (previous revision surgery).The root cause of the fractured stem, which resulted in the second revision, could not be concluded based on the imaging alone but loosening and the resulting micro-motion was again the likely root cause (reported revision surgery).The patient impact beyond the reported pain, loosening, and the two revision procedures could not be determined.No further medical assessment can be rendered at this time.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.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include but are not limited to loosening or improper device fit / sizing.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 warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: ECH POR 190MM STR SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9315168
• Report Number: 1020279-2019-03994
• Device Sequence Number: 13986201
• Product Code: LPH
• UDI-Device Identifier: 03596010328700
• UDI-Public: 03596010328700
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2025
• Device Model Number: 71340111
• Device Catalogue Number: 71340111
• Device Lot Number: 15EM19716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/31/2020; 01/31/2020; 09/23/2021
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/06/2020; 02/06/2020; 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NO.: 71303200 / LOT NO.: 15LM00944; PART NO.: 71303200 / LOT NO.: 15LM00944; PART NO.: 71333334 / LOT NO.: 15KM21831; PART NO.: 71333334 / LOT NO.: 15KM21831; PART NO.: 71336452 / LOT NO.: 15EM10480; PART NO.: 71336452 / LOT NO.: 15EM10480; PART NO.: 71336520 / LOT NO.: 15HM16505; PART NO.: 71336520 / LOT NO.: 15HM16505; PART NO.: 71336525 / LOT NO.: 15GT56784; PART NO.: 71336525 / LOT NO.: 15GT56784
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR