MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-050

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Weakness (2145); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/19/2012

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

Patient was revised to address possible hypersensitivity/metal reaction.Update: 10/17/13 - litigation papers received.Litigation alleges pain, fluid build-up and elevated cobalt and chromium levels.There is no additional information that would affect the outcome of this investigation.Update ad 09 oct 2018: in addition to what was previously reported, ppf alleges metal wear and metallosis.The patient harm and the patient experience code were updated.Added patient date of birth, expiration date, lawyer, and patient state of residence.The stem was reported under (b)(4) for the allegation after the first revision.Update ad 6 oct 2020: pfs alleges mobility, strength, discomfort and pain.Doctor also mention that chronic cough probably related.After review of medical records, it was indicated that the patient presented with right hip pain and clinical evident of a metal hypersensitivity.There was also fluid collection and marked elevated serum cobalt and chromium level.The patient was then revised for failed right tha secondary to metallosis.Operative notes reported that there was signification metal staining of the synovium capsule.It was felt that the cup position was ever so slightly vertical on x-ray.After multiple tries the liner could not be disimpacted from the cup, so it was elected to remove the cup.Doi: (b)(6) 2008 ; dor: (b)(6) 2012 (right hip) first revision.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: PINNACLE 100 ACET CUP 50MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10762719
• MDR Text Key: 213893391
• Report Number: 1818910-2020-23645
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008545
• UDI-Public: 10603295008545
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/19/2012

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 Model Number: 1217-01-050
• Device Catalogue Number: 121701050
• Device Lot Number: B88ED1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 12/06/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AML SM STATURE 12.0MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX50OD; AML SM STATURE 12.0MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX50OD
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66