MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH PRI FEM COMP HO SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	OR71341024
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mildly displaced fracture occurred through the osteotomy site of the left greater trochanter.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the reattachment of the posterior oblique trochanteric osteotomy fragment by means of drill holes in the bone and patient fall cannot be ruled out as a contributing factors to the fracture through the osteotomy site.It also cannot be concluded that the fracture was associated with a mal-performance of the implant.No subsequent documentation beyond the x-ray that identified the fracture, however the patient may require a revision to repair.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: ECH PRI FEM COMP HO SZ 14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8638425
• Report Number: 1020279-2019-02035
• Device Sequence Number: 19294061
• Product Code: LPH
• UDI-Device Identifier: 03596010440280
• UDI-Public: 03596010440280
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Model Number: OR71341024
• Device Catalogue Number: OR71341024
• Device Lot Number: 16MM10112
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: Other
• Patient Age: 66 YR