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

Catalog Number 122136054

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374); Impaired Healing (2378); Test Result (2695); No Code Available (3191); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Initial reporter occupation: lawyer.(b)(4).

Event Description

Litigation records received.Litigation alleges pain and discomfort after 1st revision: doi: (b)(6) 2020 (cup); doi: (b)(6) 2020 (head, liner, stem); dor: none reported; left hip.

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.Udi (b)(4).H6 clinical code: appropriate term / code not available (e2402) is used to capture infections (e19) and bone injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.

Event Description

Ppf alleges numerous subsequent surgeries, infections, dislocations, daily spasms in neck, right shoulder, lower right buttock, both feet and lower legs, uneven gate, unable to bear full weight, unable to perform activities of daily living.Right hip still with original implant device and still causing metalosis.After review of medical records, the patient was revised due to infection.Operative notes reported that at the distal point of the previous incision, there was a large bubble indicative of an evolving sinus tract that was draining.It was very erythematous and swollen.Once it was incised a copious amount of pus come pouring out.There was clearly a dehiscence through the iliotibial band fascia all the way down to the joint.There was still quite a bit of metal stained tissue as this was started as a metallosis case.The abductor tendon has a significant metal staining, however it was intact.We could not disimpact the stem from the sleeve.A trochanteric osteotomy was performed.There was some mild bone loss that was seen on the ct in the posterior wall and superior dome, but nothing too signification.It was indicated that 3 pack rbcs were given.Doi: (b)(6) 2003 (cup,screws,stem,sleeve).Doi: (b)(6) 2019 (head, liner).Dor: (b)(6) 2019.Left hip.

Event Description

After review of medical records it was reported that patient visit notes reported that patient had reported delayed wound healing and hematoma, dislocation, pain, swelling and hot red wound.Medical records indicated that the 2nd stage revision for infection was performed on (b)(6) 2020 and patient was implanted with competitors product.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: b5 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (device code).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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: 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10778051
• MDR Text Key: 214372186
• Report Number: 1818910-2020-23821
• Device Sequence Number: 1
• Product Code: LPH
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/30/2020

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: 05/31/2024
• Device Catalogue Number: 122136054
• Device Lot Number: J4098M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 04/06/2021; 09/22/2021; 07/18/2022
• Supplement Dates FDA Received: 04/21/2021; 10/05/2021; 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• 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: PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE MULTIHOLE II CUP 54MM; PINNACLE MULTIHOLE II CUP 54MM; PINNACLE MULTIHOLE II CUP 54MM; S-ROM M HEAD 36MM +3; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 16D-SML; S-ROM*SLEEVE PRX ZTT, 16D-SML; SROM STM ST,36+6L NK,11X16X150; SROM STM ST,36+6L NK,11X16X150; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 71 KG