MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Model Number 1246-03-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Headache (1880); Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Pain (1994); Rash (2033); Seizures (2063); Tissue Damage (2104); Burning Sensation (2146); Cramp(s) (2193); Dizziness (2194); Hypoesthesia (2352); Depression (2361); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 12/18/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

New unity record created in order to update etq complaint number (b)(4).New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- litigation papers allege: bilateral patient was implanted with depuy pinnacle hip implant in her left hip on (b)(6) 2006, and in her right hip on (b)(6) 2006.The patient's hips are defective and have caused damage to her hip joints and her body.Doi: (b)(6) 2006 - dor: unk (left side).Doi: (b)(6) 2006 - dor: unk (right side).Patient is a resident of (b)(6).Update: on (b)(6) 2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified by invoice search.Records are available for further review.Patient demographics added.Update ad 02 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metallosis, metal wear and elevated metal ions.Updated the date of implant and event date.Added date of revision, revision hospital, revision surgeon, law firm, lawyer and expiration dates to the head and liner products.Added cup, stem, apex hole eliminator and bone screws due to alleged elevated metal ions and they were removed in the ppf.Doi: (b)(6) 2006 - dor: (b)(6) 2012 (left hip).Please see (b)(4) for the 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: 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: APEX HOLE ELIM POSITIVE STOP
• Type of Device: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• 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 drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9934373
• MDR Text Key: 189922108
• Report Number: 1818910-2020-10375
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: 10603295019688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963309
• 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
• Report Date: 11/01/2011

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 Model Number: 1246-03-000
• Device Catalogue Number: 124603000
• Device Lot Number: AW1B61000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 63 KG