MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that separation of suture occurred.Tanden and inner head replaced for possible infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved our investigation cannot proceed.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.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.The medical investigation concluded that no supporting clinical/medical documents have been provided except the crp that was reported as normal.Without the requested supporting clinical/medical documents a thorough investigation cannot be performed.Should the requested information become available this complaint can be re-assessed.If the devices or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: COCR 12/14 FEM HD 26 + 0
• 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: 8075666
• Report Number: 1020279-2018-02505
• Device Sequence Number: 1732352
• Product Code: LPH
• UDI-Device Identifier: 03596010194077
• UDI-Public: 03596010194077
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 71302600
• Device Lot Number: 18DM17793
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 09/19/2019
• 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; Required Intervention