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Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Event Date 03/25/2014
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (b)(4) used to capture surgical intervention. Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. Corrective action was not indicated. No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. The reported event is considered one of the possible complications of joint replacement. The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system. Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915. Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution. The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon. From the event information received, it was not possible to determine the relationship of the device to the reported event. No information received with this individual complaint indicates that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Post market surveillance is per (b)(4). (b)(4) used to capture the surgical intervention. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event Description
Literature article received entitled "recurrent catastrophic ceramic femoral head failure in total hip arthroplasty". Literature article entitled, ¿recurrent catastrophic ceramic femoral head failure in total hip arthroplasty¿ by s. M. M. Tai, et al, published by case reports in orthopedics (2014), http://dx. Doi. Org/10. 1155/2014/837954, article id 837954, 4 pages, was reviewed for mdr reportability. The authors present a case study of two ceramic head fractures, highlighting potential risk factors for ceramic head fracture and suggest possible management strategies in such cases. A 25-year-old female underwent left index tha for the treatment of developmental dysplasia of the hip. The primary hip replacement was performed through a posterior approach using an uncemented corail titanium stem with a biolox forte alumina ceramic 28 mm, +1. 5 neck length, 12/14 tapered cone head (depuy), and a duraloc titanium acetabular shell (depuy) with an alumina ceramic liner. Given the shallow nature of the patient¿s native acetabulum, the decision was made to place the cup in the abduction angle (75°) that achieved the marriage between maximum degree of component coverage and joint stability. Approximately twenty months after her primary hip replacement, the patient noticed that her hip began to squeak intermittently. A few months later, she was participating in moderate, low impact exercise when she experienced discomfort and a grinding sensation arising from her hip. Two days later, whilst turning over in bed, she felt significant pain. The patient was referred for emergency revision surgery after radiographs identified a fractured femoral head. Intraoperative findings revealed a fractured femoral head, ceramic debris within the joint capsule, and a deeply scratched acetabular ceramic liner. The scratched liner was explanted, the fractured head fragments were removed, and a thorough lavage and debridement of the operative field was performed to oust the ceramic debris. The stem and cup were well fixed and hence left in situ. The liner was renewed with a 28mm internal diameter ¿ceramic insert for metallic cup¿ (depuy) and a biolox delta articuleze ceramic 28mm diameter, +1. 5 neck length, 12/14 tapered cone head (depuy) was applied to the trunnion of the stem. At subsequent outpatient based clinical reviews, the patient noted that her hip continued to squeak intermittently. Six years following her revision procedure, the patient was again taking part in moderate, low impact exercise, when she felt a severe pain in her hip, with the sensation of the hip dislocating. Emergency radiographs revealed a fractured ceramic head that required emergency surgical intervention. The ceramic liner was explanted together with the ceramic head fragments. The original metal acetabular shell was explanted and replaced along with the ceramic liner. The trunnion of the well-fixed femoral component was noted to be damaged. The surgeons left the stem in situ and implanted a protective trunnion sleeve. The surgeons performed a thorough lavage and debridement of the operative field to remove all the ceramic debris from the joint capsule and the surrounding tissues. The patient has had no further complications.
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Manufacturer (Section D)
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
MDR Report Key9129481
MDR Text Key166048210
Report Number1818910-2019-106513
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/27/2019 Patient Sequence Number: 1