MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Model Number 1246-03-000

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

Patient Problems Pulmonary Embolism (1498); Hypersensitivity/Allergic reaction (1907); Pain (1994); Thrombosis (2100); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

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

It was reported that there was an allergic reaction to hip replacement and they are trying to find out what kind of metals are in patient hip.Patient contact was established on (b)(6) 2020.Patient's wife states that the primary tha was performed when he was (b)(6) years old on (b)(6) 2016.After the surgery, he developed a blood clot and a saddle (very large) pulmonary embolism.Two weeks later, he developed blood clots in both legs and is now on a blood thinner.He has visited several hematologists who cannot confirm the issue that is causing his blood to clot.He has pain and a limp, but no revision is scheduled.He is agreeable to jnj obtaining his medical records to obtain part/lot in order to provide the metal make-up to determine if he has an allergy.The complaint will be updated with the above information and a task will be created to send release forms to be signed.Patient received a right depuy tha to treat pain secondary to degenerative joint disease.The procedure was completed without complications.Post-operative clinic notes indicate that the patient experienced recurring postoperative bilateral deep vein thrombi and pulmonary emboli.The patient was treated with long-term warfarin therapy.The patient was referred to a hematological specialist on (b)(6) 2020 to determine if he has an underlying clotting disorder.The medical records pertaining to the pe and dvt were not provided and the dates of the occurrences are unknown.Postoperative physical examination dated (b)(6) 2020: patient presents with right hip pain.Physical exam reveals a no joint instability and rom within normal limits.X-rays identify a well-fixed and stable right tha with no evidence of lysis or loosening.No treatment for the right hip pain is prescribed as anti-inflammatory medications are contraindicated in patients with clotting issues.To date, there have been no invasive treatments or revisions for the right tha.On (b)(6) 2016, the patient had a right total hip arthroplasty to address right hip arthritis depuy components were utilized.Doe: unknown, right 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.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.

• Brand Name: APEX HOLE ELIM POSITIVE STOP
• Type of Device: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10734743
• MDR Text Key: 213219237
• Report Number: 1818910-2020-23304
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: 10603295019688
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1246-03-000
• Device Catalogue Number: 124603000
• Device Lot Number: D16010114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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: 11/13 S-ROM 40MM M SPEC+0; ALTRX +4 NEUT 40IDX58OD; PINN SECTOR W/GRIPTION 58MM; S-ROM*SLEEVE PRX ZTT, 16D-LRG; SROM STM STD 36+12L 13X18
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 110 KG