MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MODULAR CATHCART BALL 42MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Catalog Number	136342000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Revision hip: dr (b)(6), (b)(6) hospital (b)(6) 2018.Primary implant date: (b)(6) 2018.Revision for: infection - staph.Patient presented to theatre over the weekend of 14/15 of july with infected hip.This was washed out and a vac/irrigation dressing applied.Was taken back to ot on tuesday (b)(6) for attempted revision for removal of head and replace with possible cement in cement revision of stem.At this time only a washout occurred again and vac dressing - (b)(4).Jnj representative on checking the upcoming revision date was told this had occurred last night ((b)(6) 2018) without rep present.Female patient id: (b)(6).
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 42MM OD
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• MDR Report Key: 7780899
• Report Number: 1818910-2018-66560
• Device Sequence Number: 1794115
• Product Code: LZY
• UDI-Device Identifier: 10603295032748
• UDI-Public: 10603295032748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/20/2018

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 136342000
• Device Lot Number: D16052868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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: 71 YR