MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 DURALOC SECTOR SERIES 52OD; HIP ACETABULAR CUP

Catalog Number	124580049
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the device was found less than 52mm after tested and could not use.The device's standard size is 52mm.
Additional Manufacturer Narrative
It was reported that the device was found less than 52mm after tested and could not use.The device's standard size is 52mm.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Additional narrative: depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC SECTOR SERIES 52OD
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu IN 21512 -6; CH 21512-6
• MDR Report Key: 6979290
• Report Number: 1818910-2017-27510
• Device Sequence Number: 444837
• Product Code: LPH
• UDI-Device Identifier: 10603295019589
• UDI-Public: 10603295019589
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2017

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: 124580049
• Device Lot Number: D15090303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 11/01/2017; 11/01/2017; 12/14/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/03/2017; 11/06/2017; 12/19/2017
• 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: Required Intervention
• Patient Age: 58 YR