MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-356

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Loss of Range of Motion (2032); Joint Dislocation (2374); Osteolysis (2377); Test Result (2695); No Code Available (3191); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2020

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

The patient was revised to address high cobalt levels 171 ( metal on metal hip ).Pseudo tumors were present.Doi: (b)(6) 2007, dor: (b)(6) 2020, right side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: o 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.

Event Description

Ppf alleges dislocation with closed reduction, metal wear, metallosis and elevated metal ions confirmed in medical records.Unf has no allegation provided.After review of the medical records the patient was revised to address instability with metallosis, large pseudotumor with destruction of the gluteus medius, gluteus meniscus, piriformis, vastus lateralis, osteolysis of the greater trochanter, elevated metal ions, metal wear, leg length discrepancy, loss range of motion, pulmonary embolism, neurovascular damage and pain.Operative note reported fascia was thinned and a large amount of fluid was obtain in the greater trochanter, there was pseudotumor due to metallosis, ostial lysis of the greater trochanter, necrotic tissue and bone, disrupted vastus lateralis and muscle loss.The greater trochanter was completely devoid of all tendinous attachment.Pseudutomor, necrotic tissue, bone and metal wire were all removed.There was osteolysis specifically around the acetabulum.Doi: (b)(6) 2007.Dor: (b)(6) 2020.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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H10 additional narrative: added: b1 (product problem), b5, b7, d4 (expiration date), d10, g2, h6 (impact, clinical and medical device problem codes).H6 clinical codes: appropriate term / code not available (e2402) is used to capture blood heavy metal increased.Necrosis (e2327) is used to capture necrosis and soft tissue necrosis.Corrected: a1, e1, e2, e3.E3 initial reporter occupation: lawyer.

• Brand Name: PINNACLE MTL INS NEUT36IDX56OD
• 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 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10385808
• MDR Text Key: 202235162
• Report Number: 1818910-2020-17787
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: 1218-87-356
• Device Catalogue Number: 121887356
• Device Lot Number: 2249326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 04/12/2022
• Supplement Dates FDA Received: 09/10/2020; 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2006
• 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 +1.5; ARTICULEZE M HEAD 36MM +1.5; DEPUY STEM 13.5 LARGE STATURE AML; PINNACLE MULTIHOLE II CUP 56MM; UNKNOWN HIP FEMORAL STEM; ARTICULEZE M HEAD 36MM +1.5; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 70 KG