MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH STR 190MM SZ 13 STD COLLAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71927980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	04/22/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal* it was reported that after the revision surgery of the tha right hip construct had been performed on (b)(6) 2013 (covered under (b)(4)), the plaintiff experimented intermittent, dull, sharp pain in the right hip.The plaintiff also experimented numbness and weakness on ambulation.The plaintiff was treated with medications and started feeling better 9 weeks after the surgery.The 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, the clinical root cause of the reported post revision radiating pain, numbness and weakness on ambulation cannot be determined; however, the patient¿s history of degenerative lumbar disc changes and lumbar radiculopathy cannot be ruled out as contributing factors.It cannot be concluded that the reported pain, numbness and weakness were associated with a mal-performance of the implant.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 patient reaction, medical history/condition, or post-operative healing issue.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: ECH STR 190MM SZ 13 STD COLLAR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11940889
• Report Number: 1020279-2021-05004
• Device Sequence Number: 19900626
• Product Code: JDI
• UDI-Device Identifier: 03596010475855
• UDI-Public: 03596010475855
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K963486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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 Expiration Date: 04/22/2018
• Device Model Number: 71927980
• Device Catalogue Number: 71927980
• Device Lot Number: 08DM20282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: 71343608, LOT: 10AM05246
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention