MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV COCR 10/12 TAPER FEM HD 28MM 0 EXT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	11915
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Event or Problem Description
It was reported that, after a thr performed on (b)(6) 2008, patient suffered a fall that caused pain, a bone fracture around the stem and a dislocation.This was addressed via revision surgery on (b)(6) 2022 where the universal femoral head cobalt chrome 28mm 0mm extension was explanted.Current health status of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, although supporting clinical medical documentation was not provided the pain, bone fracture, dislocation and subsequent revision were related to the patient fall.It cannot be concluded the reported event were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events cannot be determined with the limited information provided.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that in warnings and precautions that the patient should be warned that the device does not replace normal healthy bone, that the implant can break or become damaged as a result of trauma or activity including heavy labor for occupation or recreation.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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, patient condition and/or patient anatomy.The contribution of the device to the reported event could not be corroborated.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: UNIV COCR 10/12 TAPER FEM HD 28MM 0 EXT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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, TX 78735 ; 5123913905
• MDR Report Key: 15278027
• Report Number: 1020279-2022-03798
• Device Sequence Number: 17763727
• Product Code: LPH
• UDI-Device Identifier: 00885556003565
• UDI-Public: 00885556003565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Model Number: 11915
• Device Catalogue Number: 11915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/27/2022
• 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: 71305515/SYN SEL II POR HO 10/12 SZ 15
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female