MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722054

Device Problem Use of Device Problem (1670)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 03/18/2021

Event Type  Injury  

Event Description

It was reported that the patient was revised due to metallosis.Ultamet metal liner/head.The hip joint was black and green with metal debris.Additional information event in the der reported osteolysis.Product issues was suspected and contributed to the event.In addition to what was previously reported after review the patient was revised to address chronic fatigue.Operative note reported excised.There was minimal fluid aspirated and was sent for synovasure.There was a thickened native posterior capsular tissue.There was no significant osteolysis about the femoral implant.Stem remained in good condition.The cup was approx.5 degrees of abduction and it was anteverted to approx.45 degrees.The entire acetabular component were removed.There was osteolysis involving the acetabulum involving the anterior wall.Surgical inflammation and pigment laden histiocytes infiltration.Pathology report of pseudo capsule with marked hyalinization, central degenerative changes and patchy mild chronic.Iron stain shows' minimal hemosiderin.Cauterized pink tan, rubbery, soft tissue with dusky green gray, necrotic tissue.No infection found.Clinical visit reported hip pain, squeaking, popping and clicking.Doi: (b)(6) 2010, dor: (b)(6) 2021, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: PINNACLE SECTOR II CUP 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17686809
• MDR Text Key: 322696334
• Report Number: 1818910-2023-18097
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009832
• UDI-Public: 10603295009832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: 11/30/2019
• Device Catalogue Number: 121722054
• Device Lot Number: D55DG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2009
• 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: ASPHERE M SPEC 12/14 36 +1.5; PINNACLE MTL INS NEUT36IDX54OD; TRI-LOCK BPS SZ 7 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White