MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 S / +0; PROST, HIP, SEM-CNSTRND, MET/CER/POL, CMNTD OR NON-POROUS, UNCMNTD

Model Number	76539165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).
Event or Problem Description
It was reported that, after a left thr surgery performed on (b)(6) 2021 via posterior approach with anthology/r3 conc construct, the patient had dislocated hip at rehab post-op.The patient had a revision left thr surgery on (b)(6) 2021 to treat this adverse event.The components seemed well fixed and in appropriate position by surgeon.The patient was dislocating during flexion and ir during rom test.The biolox delta head 36 mm 12/14 s / +0 was removed with punch and the r3 36mm id intl dlt cer lnr 58mm was removed with a liner removal tool.The patient was trialed with 36mm heads and 36x58/20 degree liner trials and the hip seemed stable in rom.20 degree xlpe liner inserted and impacted into r3 shell, and 36mm l biolox option head impacted to retained anthology stem.The hip was stable through rom.The wound was irrigated and closed in layers.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6: the associated device was not returned for evaluation and the reported event could not be confirmed, therefore, the contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, 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 instructions for use document and the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An 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 are not limited to traumatic injury, alignment or fit size of the device used.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: BIOLOX DELTA HEAD 36 MM 12/14 S / +0
• Common Device Name: PROST, HIP, SEM-CNSTRND, MET/CER/POL, CMNTD OR NON-POROUS, UNCMNTD
• 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: 13111591
• Report Number: 1020279-2021-08950
• Device Sequence Number: 4589708
• Product Code: LZO
• UDI-Device Identifier: 03596010566959
• UDI-Public: 03596010566959
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 76539165
• Device Catalogue Number: 76539165
• Device Lot Number: 21AT45877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown