MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED PINN MAR +4 10D 28IDX48OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121928148

Device Problem Disassembly (1168)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address disassociation of the inlay from the pinnacle cup.It was also reported that the customer was reporting a dysplasia inlay.

Manufacturer Narrative

(b)(4).The medical records and x-rays were reviewed by bio engineering.The bio engineering review identified that it was unlikely that a manufacturing defect was present and that no corrective action is required no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : h39303.Device history review: reviewed the attached dhr (h39303).Found no processing variation, scrap or rework required.Sterilization was completed per requirements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Complaint description: the patient was revised to address disassociation of the inlay from the pinnacle cup.It was also reported that the customer was reporting a dysplasia inlay.

• Brand Name: PINN MAR +4 10D 28IDX48OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey IN 46582
• Manufacturer (Section G): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park; leatherhead, surrey IN ; UK
• Manufacturer Contact: chad gibson ; 700 orthopaedics drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7176107
• MDR Text Key: 96768570
• Report Number: 1818910-2018-10030
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295013457
• UDI-Public: 10603295013457
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121928148
• Device Lot Number: H39303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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: 58 YR