MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-052

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Revision of a depuy synthes acetabular cup, liner, and head.Implants removed were 52 pinnacle gription cup and a 32x52 neutral marathon liner.The 32 ceramic head was also removed as a 28 head was needed for the bi-mentum components.Primary surgery was done 5 years ago and the patient started to experience pain in 2019.The reason for revision was due to pain not loosening or implant failure.The surgeon said that the cup was oversized which was causing soft tissue irritation and pain for the patient.Cup and liner were well fixed.Stem was stable so was not revised.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the affected side was the left side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis 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.Device history lot: a worldwide lot specific complaint database search, or device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: PINN SECTOR W/GRIPTION 52MM
• 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: 11252593
• MDR Text Key: 229421597
• Report Number: 1818910-2021-02112
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010302
• UDI-Public: 10603295010302
• Combination Product (y/n): N
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2021

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
• Device Operator: Health Professional
• Device Model Number: 1217-32-052
• Device Catalogue Number: 121732052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 01/18/2021; 04/09/2021
• Supplement Dates FDA Received: 02/04/2021; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 32 CERAMIC HEAD.; PINN MAR NEUT 32IDX52OD.; PINN SECTOR W/GRIPTION 52MM.; UNKNOWN HIP FEMORAL STEM.; 32 CERAMIC HEAD; PINN MAR NEUT 32IDX52OD; PINN SECTOR W/GRIPTION 52MM; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention