MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-458

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, there was no revision reported.Primary surgery notes and primary surgery implant sticker sheets were provided.Orthopedic consultation report dated (b)(6) 2013 indicates that the patient had a slight leg length discrepancy on the right hip.It is not known if the implants on the right hip are from depuy.Clinic visit on (b)(6) 2013 reports lower back pain, stiffness, tingling and numbness along with right sided paravertebral muscle tenderness and a palpable muscle spasm.It was mentioned that the right hip was previously revised due to wear.Doi: (b)(6) 2010.Dor: none reported; (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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, 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.Device history lot : null.Device history batch : null.Device history review : null.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: ALTRX +4 NEUT 40IDX58OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9845932
• MDR Text Key: 188628481
• Report Number: 1818910-2020-08394
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016601
• UDI-Public: 10603295016601
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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 Expiration Date: 05/31/2014
• Device Model Number: 1221-40-458
• Device Catalogue Number: 122140458
• Device Lot Number: DR9PB1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUP 121732058/E15S11000; HEAD 136542600/3069298; HOLE ELIMINATOR 124603000/D09110203; LINER 122140458/DR9PB1000; SCREW 121720500/428151; SCREW 121720500/CB5FT4000; SCREW 121730500/425507; SLEEVE 550524/3050310; STEM 563618/3029743
• Patient Outcome(s): Required Intervention