MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 HA ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121711052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: pinn mar neut (b)(4); 121928052.
Event or Problem Description
Event or product problem outcome luxation of a pinnacle liner out of the pinnacle shell.The patient had bended forward, felt something gliding and heard a kind of crack.This had happened before only this time there was a lot of pain and the feeling that something was terribly wrong.Describe the 'damage' or 'other' outcome revision surgery was necessary, surgeon replaced the pinnacle system by a system of the describe event patient fell from her bicycle on her right hip and felt pain in her left hip.Competitor- patient information: (b)(6), birth date (b)(6); (b)(6), gender female ; (b)(6), weight (b)(6); (b)(6), height 1.74 meter; date the event, if different from date of procedure/surgery: primary surgery: (b)(6) 2010; revision surgery:(b)(6) 2018.
Additional Manufacturer Narrative
Product complaint #: (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: PINNACLE 100 HA ACET CUP 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7726301
• Report Number: 1818910-2018-65343
• Device Sequence Number: 996005
• Product Code: LPH
• UDI-Device Identifier: 10603295009061
• UDI-Public: 10603295009061
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 06/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121711052
• Device Lot Number: ES8JC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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: 68 YR
• Patient Weight: 89