MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333324
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr, performed sixteen year ago (2005), the patient experienced 2 recent dislocations, with the last dislocation approximately 3 weeks ago.A revision surgery was performed on (b)(6) 2021 to change reflection 28mmid size e xlpe 20 deg liner (case-(b)(4)) to constrained option and change cocr 12/14 fem head 28 +0 (case-(b)(4)).The current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, the provided photo of the explanted device was reviewed, but does not aid in determining a clinical root cause of the reported dislocations.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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 anatomy or abnormal loading of limb.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.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, the provided photo of the explanted device was reviewed, but does not aid in determining a clinical root cause of the reported dislocations.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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 anatomy or abnormal loading of limb.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: REF XLPE 28 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 13110956
• Report Number: 1020279-2021-08939
• Device Sequence Number: 11659407
• Product Code: JDI
• UDI-Device Identifier: 03596010455611
• UDI-Public: 03596010455611
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2022

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 Expiration Date: 07/29/2014
• Device Model Number: 71333324
• Device Catalogue Number: 71333324
• Device Lot Number: 04GM10440
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 02/04/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/02/2022; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNKN CPCS CEM STEM; UNKN REDAPT ACET IMPL
• Patient Sex: Unknown