MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that, 3 moths after a left revision surgery performed in (b)(6) 2015 (captured under (b)(4)), the patient experienced pain on the area.The physician diagnosed traumatic bursitis, which was treated with some physical therapy and ultrasound treatment.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, 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 reported post-revision pain is associated with the patient¿s bursitis and/or implant size and is not associated with a malperformance of the implant but is likely due to the ¿large pin¿ as reported.The patient impact cannot be determined.A review of complaint history did not reveal additional complaints for the listed batch.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 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 or patient reaction.Based on this investigation, the need for corrective action is not indicated.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.Additional information: d3.

• Brand Name: COCR 12/14 FEM HEAD 36MM +4
• 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: 11949430
• Report Number: 1020279-2021-05032
• Device Sequence Number: 16409019
• Product Code: LPH
• UDI-Device Identifier: 03596010479990
• UDI-Public: 03596010479990
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 12/19/2024
• Device Model Number: 71303604
• Device Catalogue Number: 71303604
• Device Lot Number: 14MM16138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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: R3 0 DEG XLPE ACET LNR 36MM X 52MM, LOT 13FM00576; R3 3 HOLE ACET SHELL 52MM, LOT NUMBER 13HM02361; REF INTERFIT THRD HOLE COVER, LOT 13HM178787; R3 0 DEG XLPE ACET LNR 36MM X 52MM, LOT 13FM00576; R3 3 HOLE ACET SHELL 52MM, LOT NUMBER 13HM02361; REF INTERFIT THRD HOLE COVER, LOT 13HM178787
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR