MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-058

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/09/2020

Event Type  malfunction  

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.

Event Description

Clinical adverse event received for implant fracture - s-rom stem.Event is serious and is considered severe.Event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2008.Date of event (onset): (b)(6) 2020 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of provided x-ray images confirms the reported allegation.The position of the acetabular cup is more vertical than would be recommended by depuy.Cup placement is determined by the implanting surgeon and is not considered a product problem.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Corrected: h6 code 3191 (patient) from absence of treatment to device revision or replacement.

• Brand Name: PINNACLE 100 ACET CUP 58MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10358032
• MDR Text Key: 201878415
• Report Number: 1818910-2020-17385
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008583
• UDI-Public: 10603295008583
• Combination Product (y/n): N
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-01-058
• Device Catalogue Number: 121701058
• Device Lot Number: CK7F51000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 11/13 S-ROM 40MM M SPEC+3; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; S-ROM*SLEEVE PRX ZTT, 18D-SML; SROM STM STD 36+12L 13X18
• Patient Age: 59 YR