MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-054

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

Patient Problems Ossification (1428); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Pinnacle medical records received.After review of the medical records, post revision clinical visit reported pain in left groin, lower back, weakness, numbness sensation, flexor tendinitis, bone loss in the proximal portion of the femur, local tissue reaction, ongoing iliopsoas tendinopathy.X-rays revealed heterotopic bony formation on the greater trochanter.Doi: (b)(6) 2018; dor: unknown; left hip.

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, 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.

Event Description

Medical record received.Update ad (b)(6) 2022: (b)(4), has been reopened due to the receipt of pfs and medical record.Pfs alleges that patient has limitations when walking and limited movement of any physical activity.X-rays result stated that there is a fracture fragment seen lateral to the femoral neck.

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.Added: b5, h6 (health effect - clinical code & health effect - impact code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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, 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: g1.

• Brand Name: ALTRX NEUT 36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 10487759
• MDR Text Key: 205483411
• Report Number: 1818910-2020-19354
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016335
• UDI-Public: 10603295016335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2020

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 Model Number: 1221-36-054
• Device Catalogue Number: 122136054
• Device Lot Number: H46131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 04/21/2022; 05/09/2022
• Supplement Dates FDA Received: 09/29/2020; 05/05/2022; 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 11/13 36MM +3; PINNACLE 300 ACET CUP 54MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; S-ROM*STM STD,42 NK,18X13X160; DELTA CER HEAD 11/13 36MM +3; PINNACLE 300 ACET CUP 54MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; S-ROM*STM STD,42 NK,18X13X160
• Patient Outcome(s): Required Intervention
• Patient Sex: Female