MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 28MM +3; FEMORAL HEAD

Catalog Number	152190059
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Account name: (b)(6) hospital.On (b)(6) 2014, primary tha surgery was performed using the following implants.-stem (part#: 900530210, lot#: 7834133).-sleeve (part#: 550514, lot#: 7807209).-head (part#: 152190059, lot#: 3269026).-liner (part# & lot#: unknown).-cup (part# & lot#: unknown).In (b)(6) 2017, pseudotumor was suspected based on the mri image at this hospital.In (b)(6) 2017, pseudotumor was denied through the needle biopsy at another large hospital.In (b)(6) 2017, this hospital confirmed through mri that the pseudotumor was getting bigger.On (b)(6) 2017, revision surgery was performed to replace all the implants other than the cup with new implants.The revision surgery was successfully completed.Doi: (b)(6) 2014; dor: (b)(6) 2017; unknown affected hip.
Additional Manufacturer Narrative
Investigation summary: examination of the returned device(s) could not confirm the reported event.Product problem has not been identified.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
(b)(4).Investigation summary: examination of the returned device(s) could not confirm the reported event.Product problem has not been identified.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.

• Brand Name: 9/10 COCR HEAD 28MM +3
• Common Device Name: FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7120992
• Report Number: 1818910-2017-51783
• Device Sequence Number: 1799158
• Product Code: JDI
• UDI-Device Identifier: 10603295276647
• UDI-Public: 10603295276647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2017

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: 152190059
• Device Lot Number: 3269026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 04/27/2018; 06/26/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 05/01/2018; 07/06/2018
• 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: 68 YR
• Patient Weight: 51