MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX52OD; HIP ACETABULAR LINERS

Catalog Number 121936152

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Date 03/24/2021

Event Type  Injury  

Event Description

Post-op inflammation.This case is from health authority.It was reported that the patient underwent a left hip arthroplasty for osteonecrosis of the left femur and was discharged 6 days after surgery.On the 16th day after operation, the wound of left buttock suffered from erythema, inflammation, heat and pain when the patient performed self-compress at home.On the 35th day after the operation, the patient was hospitalized again.Local subcutaneous tissue incision, drainage were performed.Dressing change and antibacterial treatment were given.After 41 days, the local erythema, inflammation, heat and pain and exudation of the wound disappeared.The patient was discharged.About 4 and half months later, the original incision site appeared mass and pain.The patient was hospitalized for the third time.No additional information could be provided.

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

Additional information received indicated that the patient was discharged 6 days after the implantation.16 days after the surgery, the patient suffered from erythema, inflammation and pain, heat.On may 24, local redness, swelling, heat pain and wound exudation disappeared and discharged.On october 12, mass and pain occurred again in the original incision and the patient was hospitalized for the third time.Affected side was the left side.

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: 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 : device associated with this report was not received for examination, however x-ray photos were provided.All available x-rays were reviewed, and it can't be determine any device related problem.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot :a worldwide complaint database search found no additional previous reports against the provided product code/lot code combination.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN MAR +4 10D 36IDX52OD
• Type of Device: HIP 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: 12851609
• MDR Text Key: 281077291
• Report Number: 1818910-2021-25957
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2021

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 Catalogue Number: 121936152
• Device Lot Number: J87A24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 02/01/2022
• Supplement Dates FDA Received: 01/12/2022; 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• 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: ARTICULEZE M HEAD 36MM +5; CORAIL2 STD SIZE 10; CORAIL2 STD SIZE 10; PINNACLE MULTIHOLE II CUP 52MM; PINNACLE MULTIHOLE II CUP 52MM; UNK HIP ACETABULAR LINER; UNK HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male