MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MULTIHOLE W/GRIPTION 48MM; HIP ACETABULAR CUP

Catalog Number 121730048

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Follow-up with the complainant has been conducted for the catalog number and lot number and this information is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision due to liner disassociation.Cup noted to be stable and intact.On 10-2-2017: medical records reviewed.Primary operative notes (b)(6) 2015 indicate the patient received a left total hip replacement due to osteoarthritis left hip.The procedure was completed without complication indicated by the surgeon.Revision notes (b)(6) 2016 indicate the patient received a left total hip revision, revision scar due to osteoarthritis left up, postoperative scar.Indication for surgery includes radiology interpretation of left total hip acetabular wear suggesting possible dissociation of the acetabular liner.Patient also reported onset of symptoms 2 weeks prior to surgery of grinding sensation.Intra-operative findings include: the acetabular liner was subluxed inferiorly.The acetabular component was found to be intact and stable.The articular plastic showed signs of wear superiorly and laterally.The femoral component was well fixed within the bone.Head, liner and apex hole eliminator were revised.Updated 10-2-2017.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed.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: PINN MULTIHOLE W/GRIPTION 48MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6928386
• MDR Text Key: 89000374
• Report Number: 1818910-2017-26199
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121730048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 11/30/2017
• Supplement Dates FDA Received: 12/01/2017; 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 77