MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX60OD; METAL ACETABULAR LINER

Model Number 1218-87-360

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

Patient Problems Erythema (1840); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle metal on metal claim letter received.Claim letter alleges pain, discomfort, difficulty walking and elevated metal ions.Mri suggested bilateral foreign body reaction with osteolysis and pseudotumor formation.Plaintiff also suffer metallosis, permanent tissue, muscle loss, limited adl and work, medical expenses, psychological and emotional injuries.Patient is seeking compensation for all the damages that have cause him.This is also serve as formal notice of claim and written demand.Doi: (b)(6) 2006, dor: unknown, left hip.This is a bilateral complaint link to (b)(4) (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.

Event Description

Litigation alleges heavy metal ions, metal debris, heavy metal poisoning resulting to injury and pain.Revision findings were metallosis, extensive abductor muscle necrosis, metallic stained fluid with evidence of metal debris, necrotic tissue, pseudo-membrane from the undersurface of the acetabular liner these are all due to toxic heavy metal ion poisoning.Doi: (b)(6) 2006, dor: (b)(6) 2021, 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.H10 additional narrative:  added: a2 (age, dob), b7, d4, h4.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).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:  added: b5, b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 clinical code: appropriate term/ code not available (e2402) was replaced with metal related pathology (e1618) to capture blood heavy metal increased and metal poisoning.

Event Description

After review of the medical records, clinical visit reported bilateral tha suggestive of bilateral foreign body reaction with osteolysis and juxta articular collection/ pseudotumor formation.

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: added: a4, a5, a6, b5, b6, b7 and h6 (clinical codes) h6 clinical symptoms code: swelling/edema (e2338) used to capture swelling and edema.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

Event Description

Update ad 13 dec 2022: in relation to aei note a-8403617, pinnacle mom medical record received.After review of the medical records the patient was revised to address failed mom left tha with metallosis and extensive abductor muscle necrosis resulting to pain, elevated metal ions, mom corrosion, pseudotumor formation and discomfort.Operative note reported bursal tissue dissected, there was metallic stained fluid 300 ml and had metal debris.There was evidence of both abductor muscle necrosis and capsular tissue necrosis and abductor muscles.There was a small amount of shuck, corrosion in the femoral head and taper on the stem.Necrotic tissue was removed of the acetabulum.There was also corrosion at the taper of the liner with pseudo membrane formation.Clinical visit reported left hip and back pain, weakness, mass lesion was noted on the mri.Suggestive of bilateral foreign body reaction with osteolysis and juxta articular collection/ pseudotumor formation.Clinical visit reported mechanical loosening of internal left tha, however, there is no further details regarding this mention of loosening.Lab result for metal ions is above 7ppb.Update ad 20 dec 2022: in relation to aei note a-8439710, medical records received.In addition to what was previously reported on the medical records.After review of the records, clinical visit reported on (b)(6) 2021 patient had continued to have moderate effusion of his l hip, strength limitation, persistent edema and limited adl.On (b)(6) 2021 clinical finding reported significant bruising left hip with significant effusion post left hip revision.There was also swelling and redness.Initiated medical records review for the non mom hip construct assigned to our clinician for possible new complaint to capture the reported harm post left hip revision.

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.In addition to previous reported harm.After review of the medical records the patient had a sensation of numbness in his lateral hip and developed metalosis, with small tumor behind the hip due to metal on metal reaction.His muscle was disintegrating around the joint to the point he could not walk.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of wear or anything indicate of a device nonconformance was found.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: PINNACLE MTL INS NEUT36IDX60OD
• Type of Device: METAL ACETABULAR LINER
• 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 dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12434507
• MDR Text Key: 270170362
• Report Number: 1818910-2021-19444
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: 1218-87-360
• Device Catalogue Number: 121887360
• Device Lot Number: 2084460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2006
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +12; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE MULTIHOLE II CUP 60MM; TRI-LOCK 10.0MM LAT OFFSET; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White