MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXNM FEM HD 28MM +12; PROSTHESIS HIP SEMICONSTRAINED METAL/CRMC/POLY CEMENTED OR NONPOROUS UNCEMENTED

Catalog Number	71342812
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through an x-ray image that the patient presented a dislocation of the implant's femoral head.It is unknown the date or side of dislocation.It is unknown what medical intervention was performed to correct the adverse event.No more information is available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.The clinical/medical investigation concluded that the intraoperative findings of the reported elevated metal ion levels may be consistent with findings associated with metal debris; however, the root cause of the reported symptoms noted in the legal claim cannot be concluded and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined.No further clinical assessment is warranted at this time.

• Brand Name: OXNM FEM HD 28MM +12
• Common Device Name: PROSTHESIS HIP SEMICONSTRAINED METAL/CRMC/POLY CEMENTED OR NONPOROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8345226
• Report Number: 1020279-2019-00579
• Device Sequence Number: 1058046
• Product Code: LZO
• UDI-Device Identifier: 03596010474186
• UDI-Public: 03596010474186
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 08/07/2023
• Device Catalogue Number: 71342812
• Device Lot Number: 13HM06617
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: PN 71357105 BN 08LM12587A ANTHLGY HO POR PL HA SZ5; PN 74120156 BN 091504 ACETLR CUP HAP 56MM W/ IMPTR; PN 71357105 BN 08LM12587A ANTHLGY HO POR PL HA SZ5; PN 74120156 BN 091504 ACETLR CUP HAP 56MM W/ IMPTR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention