MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887350

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Tissue Damage (2104); Depression (2361); Test Result (2695); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 07/13/2011

Event Type  Injury  

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

Ppf alleges elevated metal ions while pfs alleges spasms, pain, instability, fatigue and fall.After review of medical records, the patient was revised to address aseptic failure total right hip arthroplasty.There was no mention of stem loosening.Doi: (b)(6) 2010 - dor: (b)(6) 2011 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = **updated due to re-open** 10 sept 2020- ppf and product stickers received.There is no new additional information that would affect the existing mdr decision.The devices associated with this report were not returned.A previous review of the device history records did not reveal any related manufacturing anomalies.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to determine a root cause, the need for corrective action was not indicated.No code available (3191) is used to capture fall, joint instability and surgical intervention.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.After a review of medical records, revision notes were reported of serous fluid.The liner, head, and stem were removed from the canal with minimal bone attachment.Clinic visits reported of large pseudotumor, swelling, and painful right lateral condyle above the head of the fibula.Psuedutomors contain metal ions, osteocytes, wbcs, fluid, and osteolysis.Bone scan reported of periprosthetic fracture.Cortical fracture emanating from the tip of the prosthesis.Metal debris generated from taper junctions appears to be of a different morphology.It was also reported that the implant was likely already corroded when it was inserted.There was also consistent of inflammation and systemic cobalt toxicity from total hip arthroplasties.Updated event description: on (b)(6) 2010 during the clinic visit, a large pseudotumor began swelling, very hard and painful, on the right lateral condyle above the head of the fibula, about the size of a golf ball.Pseudotumors contain metal ions, osteocytes, wbcs, and fluid.On (b)(6) 2010, the patient had a right total hip replacement to address degenerative arthritis.It was noted that an aml prosthesis was implanted in the femur along with other components.On (b)(6) 2010 (right hip) large pseudotumor, began swelling, very hard and painful.Pseudotumor is smaller (8 years later).On (b)(6) 2010 periprosthetic fracture, cortical fracture emanating from the tip of prosthesis.(no specifics noted).On (b)(6) 2010 body scan of hips demonstrates mild increased activity surrounding the right hip prosthesis.This is consistent with postoperative changes.Mild loosening cannot be excluded as this would have a similar appearance.History of total hip replacement (b)(6) 2010, vertical fracture at tip of prosthesis.(b)(6) 2011 cobalt 1.7 ppb, chromium 1.4 ppb, co/cr = 1.21.(b)(6) 2011 cobalt 2.7 ppb, chromium 1.4 ppb, co/cr = 1.92.(b)(6) 2011 cobalt 2.6, chromium 1.9, co/cr 1.36.On (b)(6) 2011 the patient had a revision total hip arthroplasty, right side to address aseptic failure.

• Brand Name: PINNACLE MTL INS NEUT36IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8459463
• MDR Text Key: 140147063
• Report Number: 1818910-2019-88771
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• 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
• Report Date: 06/20/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887350
• Device Lot Number: 3039717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2009
• 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: 6IN AML LRG STATURE 10.5 MM.; ASPHERE M SPEC 12/14 36 +1.5.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP ACETABULAR HOLE ELIMINATOR.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 66 KG