MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 48MM OD; HIP FEMORAL HEAD

Catalog Number	136348000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Der states that patient had hemi hip implanted on (b)(6) 2017.Patient started experiencing pain and was brought back to or last (b)(6) 2017 and it was determined that patient had infected hemi hip.The head ball and sleeve were removed and a hip joint washout was performed.The original stem was left implanted.
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
Update sep 12, 2017.Medical records reviewed.It is indicated the patient received a hemiarthroplasty of the right hip due to displaced femoral neck fracture post fall.Approximately 7 weeks post hemiarthroplasty the patient presented to the ed with right hip pain.Infection workup revealed positive staphylococcus epidermis; the final impression concluded to be prosthetic joint infection.It is also indicated within the medical records that the patient went on to receive a revision of the femoral component and head exchange with incision and debridement and placement of antibiotic beads.Updated 10-4-2017.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 48MM OD
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46582 0988
• MDR Report Key: 6803910
• Report Number: 1818910-2017-23065
• Device Sequence Number: 11155570
• Product Code: LZY
• UDI-Device Identifier: 10603295032809
• UDI-Public: 10603295032809
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/12/2017

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: 136348000
• Device Lot Number: D17031948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 09/12/2017; 09/12/2017; 05/17/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 10/02/2017; 10/04/2017; 05/21/2018
• 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: 70 YR
• Patient Weight: 74