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 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); No Code Available (3191)

Event Date 10/28/2011

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: 10/25/2012 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 stikcer sheets.In addition to what were previously alleged, ppf alleges metallosis, metal wear and elevated metal ions.Added stem alleged elevated metal ions.Updated patient harm.Added lawyer in the associated contact.Doi: (b)(6) 2006 - dor: none reported (right hip).Patient is bilateral.See (b)(4) for the left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 9937961
• MDR Text Key: 189989802
• Report Number: 1818910-2020-10429
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: 10603295019688
• Combination Product (y/n): N
• PMA/PMN Number: K963309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: A5BDV1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 63