MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	76539166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a second revision surgery was performed due to patient dislocating.The r3 36mm id dlt cer lnr mm64 with metal sleeve and biolox delta head 36 mm 12/14 m were removed.The procedure was completed with sn back up devices.It is unknown it there was a surgical delay.No other complications were reported.(the previous reported revision surgery was due to head implant breakage).All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: it was reported that, a second revision surgery was performed due to dislocation.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As batch information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical evaluation noted that no medical information is available, and there are no surgical records or x-rays to be provided.Therefore, due to insufficient information, a thorough clinical assessment cannot be performed.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time or patient medical history.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11113619
• Report Number: 1020279-2021-00065
• Device Sequence Number: 11664938
• Product Code: LZO
• UDI-Device Identifier: 03596010566966
• UDI-Public: 03596010566966
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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 Model Number: 76539166
• Device Catalogue Number: 76539166
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention