MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 190MM STR SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71340111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken prosthesis.
Additional Manufacturer Narrative
The associated echelon porous straight stem was returned and evaluated.A lab analysis conducted during this investigation indicated that the stem is fractured at the proximal section of the device.There is little to no bone growth on the distal section of the stem indicating that the stem was not fixated within the bone.Also, the porous coating was sheared on one side of the stem; this was likely caused by removal of the device.The coronal slot in the distal tip of the stem was compressed, this likely occurred in vivo or during removal.No material or manufacturing deviations were identified in this investigation.Our investigation including a review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The batch number was provided for the device.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the implanted devices failed to meet specifications.A clinical evaluation noted that no clinical supporting documents were provided to confirm the reported issue or to determine the root cause of this reported occurrence.However, the lack of bone ingrowth identified in the explant analysis along with possible micro-motion could have been a contributing factor the reported broken prosthesis, although the implantation date remains unknown.The patient may experience possible pain or brief post-op rehab.No further clinical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: ECH POR 190MM STR SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8210007
• Report Number: 1020279-2019-00013
• Device Sequence Number: 11176867
• Product Code: JDI
• UDI-Device Identifier: 03596010328700
• UDI-Public: 03596010328700
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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 Catalogue Number: 71340111
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: Hospitalization; Required Intervention