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

Catalog Number	121928148
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2017
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.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey IN 46582
• MDR Report Key: 7176107
• Report Number: 1818910-2018-10030
• Device Sequence Number: 16495764
• Product Code: LPH
• UDI-Device Identifier: 10603295013457
• UDI-Public: 10603295013457
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 121928148
• Device Lot Number: H39303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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: 58 YR